To compare the intraocular pressure lowering efficacy and side effect profile of travoprost 0.004%/timolol 0.5% ophthalmic solution dosed in the morning and evening.
This was a multicenter, prospective, randomized, double-masked, parallel group clinical study of 92 patients with open-angle glaucoma (with or without pseudoexfoliative or pigmentary glaucoma) or ocular hypertension. After a washout of existing glaucoma medications, patients were randomly assigned to receive one drop of travoprost 0.004%/timolol 0.5% in the morning or evening for 6 weeks. The main outcome measures were mean intraocular pressure (IOP) assessed at 9 am, 11 am, and 4 pm, and safety variables.
Travoprost 0.004%/timolol 0.5% ophthalmic solution, dosed in the morning or evening, controlled IOP consistently throughout the day. Mean IOP ranged from 16.5 to 16.7 mmHg in the morning treatment group and from 16.1 to 17.2 mmHg in the evening treatment group. Travoprost 0.004%/timolol 0.5% ophthalmic solution produced statistically significant and clinically relevant reductions in IOP from baseline; mean reductions ranged from approximately 8 to 10 mmHg (32% to 38%). Travoprost 0.004%/timolol 0.5% ophthalmic solution was safe and well tolerated with the most frequently reported adverse event being ocular hyperemia, which occurred in 12.5% of patients in the morning treatment group and 13.6% of patients in the evening treatment group.
Travoprost 0.004%/timolol 0.5% given once daily, either in the morning or evening, is a safe and effective treatment for open-angle glaucoma and ocular hypertension. It may be beneficial for patients judged to be inadequately controlled on a prostaglandin analogue or ophthalmic beta-blocker alone.
The objective of the study was to compare the intraocular pressure (IOP)-lowering efficacy and safety of travoprost 0.004%/timolol 0.5% ophthalmic solution (Trav/Tim) to latanoprost 0.005%/timolol 0.5% ophthalmic solution (Lat/Tim), dosed once daily in the morning, in patients with open-angle glaucoma (OAG) or ocular hypertension (OH).
This was a randomized, double-masked, multicenter, parallel group, active-controlled study conducted at 41 sites. At the eligibility visit the patients were randomized (1:1) to the assigned masked medication if they met inclusion/exclusion criteria, and the mean IOP values in the eligible eyes were > or =24 mmHg at 9 AM and > or =21 mmHg at 11 AM and 4 PM. Patients were excluded if the mean IOP in either eye was >36 mmHg. Patients were instructed to administer the assigned medication each morning at 9 AM. During the treatment phase of the study, IOP was measured at 9 AM at week 2, week 6, month 3, and month 9. At the month 6 and month 12 visits, IOP was measured at 9 AM, 11 AM, and 4 PM. Statistical methods included a repeated measures analysis of variance (ANOVA); to test for noninferiority, a 95% confidence interval for the treatment group difference was constructed based on the ANOVA results for each time point at month 12.
Patients (n=408) with OAG or OH were enrolled at 41 sites. One patient withdrew prior to receiving medication so 207 in the Trav/Tim group and 200 in the Lat/Tim group were evaluable for safety. Baseline demographic characteristics as well as IOP values showed no statistical differences between the two groups. Trav/Tim provided lower mean IOP values than Lat/Tim that were statistically significant at the week 2 9 AM (p=0.0081), month 6 9 AM (p=0.0056), and month 6 11 AM (p=0.0128) time points and at 9 AM time point pooled across all visits (p=0.0235) when mean IOP was 0.6 mmHg lower in the Trav/Tim group. Treatment-related adverse events were mild in both groups. Although hyperemia was reported from a higher percentage of patients in Trav/Tim group, differences in average hyperemia scores between the two groups were not considered clinically relevant.
Travoprost 0.004%/timolol 0.5% ophthalmic solution produced mean IOP levels that are statistically noninferior to latanoprost 0.005%/timolol 0.5% ophthalmic solution. Furthermore, at 9:00 AM, 24 hours after dosing, IOP was statistically lower for travoprost 0.004%/timolol 0.5% pooled across all visits. Travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution is an effective treatment for reducing IOP and it is safe and well-tolerated in patients with OAG or OH.
To determine if a test formulation of latanoprost 0.005% (Bausch & Lomb) eyedrops reduced intraocular pressure (IOP) as well as Xalatan® (latanoprost 0.005%) in patients with ocular hypertension (OH) or primary open-angle glaucoma (POAG).
This multicenter, randomized, investigator-masked, parallel-group study allocated 266 patients with OH or POAG in a 1:1 ratio to latanoprost or Xalatan administered once daily for 6 weeks. The primary endpoint was the mean change in 8:00 AM IOP of the study eye from baseline to week 6. Secondary endpoints included mean change in 8:00 AM IOP from baseline to week 2, and in 12:00 noon and 4:00 PM IOP from baseline to week 2 and week 6. The safety and tolerability of both drugs were also assessed.
Both study groups had comparable demographics and baseline characteristics. The mean (SD) change in 8:00 AM IOP from baseline to week 6 was -7.29 (2.61) and -7.54 (2.80) mmHg with latanoprost and Xalatan, respectively. Latanoprost was found noninferior to Xalatan in the primary analysis (mean [SEM] treatment difference, 0.252 [0.504] mmHg; 95% confidence interval [CI] -0.408, 0.913; p = 0.0001; noninferiority margin, 1.5 mmHg) and met the predefined definition of equivalence to Xalatan (95% CI within [-1.5, 1.5 mmHg] margin). The IOP-lowering effects of latanoprost and Xalatan were comparable at all assessed time points. Both study treatments demonstrated a comparable safety and tolerability profile.
Bausch & Lomb latanoprost 0.005% is clinically equivalent to Xalatan for treating OH and POAG as demonstrated through this unique comparative trial.
To assess the cost-effectiveness of treatment strategies that utilize first-line latanoprost compared to those based on initial beta-blocker therapy in patients with open-angle glaucoma (OAG) or ocular hypertension (OH) in France.
The study was based on a decision-analytic model that was populated with data from a retrospective chart review. A hypothetical cohort of patients newly diagnosed with OAG and/or OH was assessed over a period of 2 and 3 years. For each treatment strategy 10,000 patients were assumed.
First-line latanoprost therapy was significantly more effective than initial treatment with a beta-blocker, providing more days of intraocular pressure (IOP) control primarily due to its longer time until initial treatment failure. Latanoprost's higher acquisition cost was largely offset by reductions in costs associated with surgical procedures. The additional cost for latanoprost was estimated at approximately 41 Euro and 27 Euro over 2 and 3 years, respectively. The incremental cost per day of IOP control when latanoprost was used as first-line strategy compared to the first-line beta-blocker strategy was 0.82 Euro and 0.36 Euro over 2 and 3 years, respectively.
These results provide compelling evidence that first-line latanoprost therapy can provide superior clinical outcomes at a small additional cost in actual clinical practice.
To compare the safety and efficacy of the fixed combination product with non-fixed combination use of the same active ingredients in separate bottles (bimatoprost once-daily [qd], and timolol twice-daily [bid]). A bimatoprost 0.03% qd treatment arm was used for validation of the study.
This was a double-masked, randomized, parallel study in 445 patients with open-angle glaucoma or ocular hypertension. They were randomized in a ratio of 2:2:1 to receive bilateral treatment with the fixed combination, non-fixed combination treatment, or bimatoprost alone.
Comparing the fixed combination and non-fixed combination, the non-inferiority margin of 1.5 mm Hg was met at all three timepoints for mean intraocular pressure (IOP), and a margin of 1.0 mm Hg for mean diurnal IOP. The incidence of conjunctival hyperemia was statistically significantly lower (p=0.014) in the fixed combination group (8.5%, 15/176) compared with the bimatoprost group (18.9%, 17/90) and the non-fixed combination group (12.5%, 22/176).
The fixed combination of bimatoprost 0.03%/timolol 0.5% administered once daily was comparable in ocular hypotensive efficacy to the non-fixed combination. The lower propensity of the fixed combination to elicit conjunctival hyperemia suggests a superior comparative benefit/risk assessment of the fixed combination in the treatment of elevated IOP.
To evaluate the control of diurnal intraocular pressure (IOP) and the safety profile of bimatoprost in pseudoexfoliative glaucoma (PXG) compared to primary open angle glaucoma (POAG).
A prospective, observer-masked, nonrandomized study was performed. Seventy consecutive patients with either POAG (35 eyes) or PXG (35 eyes) drug-naive for glaucoma were assigned to receive bimatoprost 0.03% once daily for 12 weeks. Diurnal IOP was measured at baseline and after 12 weeks at three time points (8 AM, noon, and 4 PM). Main outcomes were diurnal IOP control and achievement of target IOP (CIGTS criteria). Mean diurnal IOP, hour-by-hour IOP measurements, and safety, including serious adverse events, were also evaluated.
A significant IOP reduction from baseline was found in both groups (p<0.001). Mean and hour-by-hour IOP differences between groups were not statistically significant (NS). The observed IOP values and percentages of IOP reduction were 17.0 mmHg (31.5%) and 16.4 mmHg (31.9%) in PXG and POAG eyes, respectively; the differences were not statistically significant. Six eyes (1 POAG and 5 PXG, respectively) responded with a <20% IOP reduction (NS). Twenty-seven POAG (77.1%) and 23 PXG (65.7%) eyes achieved target IOP. Consequently,20 eyes (8 POAG and 12 PXG, respectively) were classified as unable to achieve the IOP target values (NS).
Bimatoprost was effective and safe in lowering IOP both in open angle and pseudoexfoliative glaucoma, achieving target pressure in most patients. However, long-term efficacy in PXG must be evaluated.
To determine the efficacy and safety of bimatoprost given every evening versus the dorzolamide/timolol fixed combination (DTFC) given twice daily in open-angle glaucoma and ocular hypertensive patients.
A double-masked, three-center, prospective, randomized, crossover comparison with two 8-week treatment periods following a 4-week medicine free washout period. Diurnal curve intraocular pressures (IOPs) were taken at 08:00 (trough) and 10:00 and 16:00 hours.
A total of 35 patients were enrolled and 32 completed all evaluations. The diurnal untreated baseline intraocular pressures was 24.8 +/- 2.4 mmHg. On the last day of treatment the mean diurnal intraocular pressures was 17.4 +/- 2.9 for bimatoprost and 18.1 +/- 2.8 mmHg for DTFC (p = 0.35). The individual time points for intraocular pressures were not statistically different between groups. Both groups statistically reduced the intraocular pressures from baseline for each time point and for the diurnal curve (p < 0.05). Regarding ocular safety and tolerability, there was more conjunctival hyperemia with bimatoprost (n = 15) than with DTFC (n = 7, p = 0.013) and more burning and stinging with DTFC (n = 12) than with bimatoprost (n = 0, p = 0.0005). Few systemic adverse events were recorded and there was no statistical difference between groups for any individual event (p > 0.05).
This study indicates that the intraocular pressures are lowered to a statistically similar amount with DTFC compared to bimatoprost in open-angle glaucoma and ocular hypertensive patients.
The aim of the study was to assess the efficacy and safety of 0.05% levocabastine eyedrops (H1 receptor blocker given BID + vehicle BID) compared with 0.1% lodoxamide ophthalmic solution (mast-cell stabilizer instilled QID) in reducing ocular signs and symptoms of allergic conjunctivitis.
A randomized, double-masked, parallel-group study was conducted in seven centres in France, in which 93 patients suffering from seasonal or perennial allergic conjunctivitis were randomly allocated to either 0.05% levocabastine (n = 47) or 0.1% lodoxamide (n = 46) in both eyes for a 14-day period. Efficacy was evaluated by subjective (prickling, burning, photophobia, itching) and objective (redness, chemosis, eyelid edema, tearing) sign scores at visits on days 7 and 14, and from data noted daily by the patient in a self-evaluation form. Safety was assessed as tolerance upon instillation and adverse event reports.
The ocular allergy symptom and sign scores were comparable in the two treatment groups at baseline. With time, statistically and clinically significant reductions (p < 0.001) from baseline were observed for the subjective and objective scores, with no difference between the treatment groups. After the first instillation, signs were alleviated more rapidly in levocabastine-treated patients than in the lodoxamide group (p < 0.001). Overall assessments by the patient and investigator were similar in both groups. No serious adverse events were reported.
Levocabastine ophthalmic suspension 0.05% (BID) appears to be as effective and safe as lodoxamide 0.1% (QID) in the management of allergic conjunctivitis.
To compare the clinical efficacy and safety of lodoxamide 0.1% ophthalmic solution with levocabastine 0.05% ophthalmic suspension, each given four times daily (QID) for three months to patients with vernal keratoconjunctivitis (VKC).
The study was conducted multinationally according to a triple-masked parallel design in 95 VKC patients, with assessments at baseline then monthly during the three months of treatment. The primary efficacy variables were a Physician's Clinical Judgement Scale and a Patient's Overall Judgement Scale of improvements from baseline. Signs and symptoms of VKC were also assessed.
Both primary efficacy variables showed significantly greater overall improvement of VKC from baseline with lodoxamide than levocabastine. The superiority of lodoxamide was demonstrated by the Physician's Clinical Judgement Scale at months 2 and 3, with a trend, at month 1, and by the Patient's Overall Judgement Scale at months 1, 2 and 3. All signs and symptoms of VKC improved significantly from baseline at all time points, regardless of treatment (p<0.001). However, relative to levocabastine, conjunctival discharge, photophobia and lacrimation were significantly reduced by lodoxamide at months 1, 2 and 3, itching at months 2 and 3, and bulbar conjunctiva at month 3. The temporal improvement of superior tarsal papillae did not differ significantly between treatments. Both were well tolerated.
Lodoxamide 0.1% and levocabastine 0.05% eye drops, instilled four times daily for three months, were effective, safe and well tolerated by patients with VKC, but lodoxamide was significantly superior to levocabastine.
This prospective study examines the changes in short-term intraocular pressure (IOP) in patients with wet age-related macular degeneration (AMD) receiving intravitreal injections of 0.05 mL ranibizumab (Lucentis) in a supine position.
A total of 45 eyes (45 patients, 16 M, 29 F, mean age: 78 y) received intravitreal ranibizumab injections for treatment of wet AMD (0.05 mL = 0.5 mg). The IOP was measured by Schiötz tonometry immediately preoperatively and postoperatively, and also after 3 and 10 minutes in a supine position. No history of glaucoma was present.
The mean preoperative IOP was 22.4+/-5.5 mmHg in supine position. Immediately after the injection, IOP increased to 47.9+/-15.1 (range 23-82, p<0.001), with 32 eyes (71.1%) >40 and 19 eyes (42.2%) >50 mmHg. The mean difference between preoperative IOP and immediately after the injection was +25.5+/-13.6 mmHg. IOP decreased spontaneously by the first 3 minutes after operation by 12.6+/-6.0 mmHg and after 10 minutes by 21+/-9.4 mmHg. The mean difference between preoperative IOP and 10 minutes postoperatively was +4.6+/-7.0 mmHg (range: -9.3 to +25.9 mmHg, p<0.001). Eyes without a subconjunctival reflux had a higher increase in IOP than eyes with any reflux (p<0.001).
IOP increased significantly in a considerable number of patients after intravitreal ranibizumab injections. A rapid and spontaneous decline was observed in the majority of cases. If there is no subconjunctival reflux after the injection, the increase in IOP is higher than in eyes with any backflow under the conjunctiva.
To assess the efficacy of nedocromil sodium 2% eye drops and emedastine difumarate 0.05% eye drops in controlling the ocular allergic reaction induced by conjunctival allergen challenge (CAC).
Thirty subjects with a personal history of allergic conjunctivitis were enrolled (first visit). At the second visit each subject randomly received emedastine 0.05% or nedocromil 2% in one eye and placebo in the other eye. Five minutes after the medication the offending allergen was instilled in both eyes. Ocular redness and itching were evaluated according to a standardized scoring system at 3, 10 and 20-minute intervals after instillation of the allergen. After one week (third visit) the whole procedure was repeated using the placebo in the eye used as control during second visit and one of the trial drug that was not used at second visit in the other eye (either emedastine or nedocromil).
Emedastine 0.05% and nedocromil 2% eye drops were more effective than placebo in controlling ocular redness and itching (p<0.01). Emedastine was more effective (p<0.01) than nedocromil in alleviating redness and itching 3 and 10 minutes after application of the allergen.
Emedastine 0.05% appeared superior to nedocromil 2% in producing immediate relief when subjects with allergic conjunctivitis were exposed to the offending allergen.
To determine the efficacy of timolol 0.1% gel in preventing increased intraocular pressure (IOP) after uncomplicated cataract surgery.
In this prospective, double-blinded, randomized study were enrolled 70 patients who underwent uncomplicated cataract surgery with phacoemulsification and intraocular lens implantation. After cataract surgery, 25 patients received a single instillation of timolol 0.1% gel (group A); 20 a single instillation of timolol 0.5% eyedrops (group B); and 25 no treatment (group C). The IOP was measured before surgery (T0) and 5 minutes (T1), 2 hours ± 30 minutes (T2), 4 hours ± 30 minutes (T3), and 24 hours ± 180 minutes after surgery (T4).
The patients in groups A and B had lower mean IOP values than those in group C at T2, T3, and T4; IOP was higher at T2 and T3 than at T1 in the control group. The IOP spikes in group C were higher than those observed in groups A and B: at T2, they were observed in 40% of the patients in group A, 30% in group B, and 76% in group C; and at T3, in respectively 20%, 10%, and 68%; and at T4, in respectively 4%, 0%, and 28%.
Timolol 0.1% gel is as effective as timolol 0.5% eyedrops in reducing IOP and in limiting the occurrence of IOP spikes for up to 24 hours after phacoemulsification.
To compare the efficacy and safety of diclofenac sodium 0.1% eyedrops packaged in an Abak multidose container without preservative (Dicloabak) with the reference product, sodium merthiolate-preserved diclofenac sodium 0.1% eyedrops, in controlling postoperative inflammation after cataract surgery.
The multicenter, controlled, randomized, single-masked study included 194 patients (Dicloabak 96, preserved diclofenac 98) scheduled to have cataract surgery by phacoemulsification with foldable intraocular lens. All were evaluated preoperatively and postoperatively after 1, 7, and 28 days. Postoperative inflammation was measured by the total score of anterior chamber cells and flare. Ocular plin, conjunctival hyperemia and ciliary flush were also assessed. Postoperative patient assessments also included visual acuity, objective tolerance by slit-lamp, fluorescein test, and subjective evaluation of local tolerance.
There was no statistically significant difference between the groups in the total score of flare and cells or the degree of conjunctival hyperemia and ciliary flush at any study visit. Dicloabak was demonstrated to be not inferior to preserved diclofenac at all assessment times. The overall assessment of local tolerance was similar for both study medications.
Preservative suppression did not alter diclofenac efficacy. Results support the good safety profile of both formulations when dosed three times daily for 4 weeks in absence of concomitant use of drugs potentially toxic for cornea. Preservative-free formulations like Dicloabak should be preferred to generic diclofenac formulations including other ingredients and may improve the safety profile of this topical nonsteroid anti-inflammatory drug.
To compare the efficacy and tolerance of fluorometholone 0.1% acetate and fluorometholone 0.2% eyedrops in the postoperative management of photorefractive keratectomy (PRK).
A randomised single-blind comparative study was performed on two groups of 30 patients who underwent myopic PRK. The first group was given fluorometholone 0.1% acetate and the second fluorometholone 0.2%. Uncorrected and best corrected visual acuity, haze, IOP and local tolerance were evaluated. Statistical analysis was done using parametric and non-parametric tests.
Visual acuity did not differ in the two groups; both were homogeneous as far as refractive error and haze were concerned. Three patients (10%) treated with fluorometholone 0.2% and two patients (6.6%) with fluorometholone 0.1% acetate developed ocular hypertension, but this was not statistically significant.
Fluorometholone 0.1% acetate was effective on inflammation after PRK, with the same efficacy as fluorometholone 0.2%.
To assess the efficacy, tolerance, and ocular tolerability of a fixed-dose combination of 0.1% diclofenac plus 0.3% tobramycin ophthalmic solution compared with 0.1% diclofenac (Voltaren) and 0.3% tobramycin (Tobrex) in patients undergoing cataract extraction by either nuclear expression (extracapsular) or ultrasound-assisted aspiration (phacoemulsification) with intraocular lens implantation.
Eighty-eight patients undergoing cataract extraction with intraocular lens implantation participated in a randomized, parallel, observer-masked trial, in which the clinical usefulness of a fixed-dose combination of 0.1% diclofenac plus 0.3% tobramycin ophthalmic solution, two eyedrops every 6 hours (n = 44) was compared with Voltaren and Tobrex, one drop of each every 6 hours (n = 44) in a 22-day course. Efficacy was assessed from changes of the sum of anterior chamber cell count plus flare, conjunctival hyperemia and edema, and ciliary congestion, by means of slit lamp biomicroscopy on days 1, 7, 14, and 21. Tolerance and ocular tolerability were assessed by recording intraocular pressure (IOP), side effects, and the patient's and investigator's opinions.
Anterior chamber cell count plus flare showed no differences in the two treatment groups at any evaluation point. The study treatment was associated with a significantly higher score for conjunctival edema on day 1 (p = 0.015), conjuncitval hyperemia on day 14 (p = 0.009) and anterior chamber cell count on day 21 (p = 0.04), but these differences had no clinical relevance. No side effects related to the study treatment were recorded.
Efficacy, tolerance, and ocular tolerability of a fixed-dose combination of 0.1% diclofenac plus 0.3% tobramycin ophthalmic solution were comparable to Voltaren plus Tobrex for the control of anterior chamber inflammation after cataract surgery, with the advantage that both active principles are supplied in a single container.
To compare the efficacy and tolerance of piroxicam 0.5% ophthalmic solution and diclofenac sodium 0.1% ophthalmic solution in controlling inflammation after phacoemulsification and intraocular lens (IOL) implantation.
Ophthalmological Department, San Donà di Piave Hospital, Venice, Italy.
Forty consecutive patients--18 men and 22 women--between 55 and 85 years of age (mean age, 75.1 +/- 7.12 years) who were scheduled for cataract extraction with phacoemulsification and IOL implantation were randomized to receive 0.5% piroxicam ophthalmic solution (piroxicam group, 20 patients) or 0.1% diclofenac sodium ophthalmic solution (diclofenac group, 20 patients) for 1 month postoperatively. Best-corrected visual acuity (BCVA) and intraocular pressure (IOP) measurements and slit-lamp biomicroscopy for the evaluation of corneal edema, Descemet membrane folds, Tyndall, and cells in the anterior chamber were carried out in all patients 1 day, 4 days, and 1 month postoperatively. Subjective symptoms after the nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution instillation were assessed using a questionnaire.
There were no significant differences between the two groups in postoperative IOP, BCVA, anterior chamber flare and cell levels, corneal edema, or Descemet membrane folds. Ocular discomfort, evaluated as burning or stinging sensation after NSAID ophthalmic solution instillation, was significantly more frequent and intense in the diclofenac-treated eyes. Two eyes in the diclofenac group had a mild transient punctate keratitis.
These results suggest that piroxicam is as effective as diclofenac sodium in preventing inflammation after cataract surgery with IOL implantation, and its better tolerance and safety can provide higher patient compliance.
To study the effects of a low administration rate and low concentration (0.1%) of clobetasone butyrate eyedrops in patients with Sjögren syndrome (SS).
This prospective, double-masked, randomized, placebo-controlled study included 40 subjects divided into 2 treatment groups: group 1 (2% polyvinylpyrrolidone eyedrops and placebo) and group 2 (2% polyvinylpyrrolidone and 0.1% clobetasone butyrate, 1 drop BID). The treatment lasted for 30 days, with visits at enrollment, baseline, day 15, day 30, and after 15 days of treatment discontinuation. At each visit, symptoms questionnaire, tear film break-up time, corneal fluorescein stain, lissamine green stain, conjunctival impression cytology for human leukocyte antigen-DR (HLA-DR) expression, intraocular pressure (IOP) measurement, and fundus examination were performed.
No changes in IOP or fundus examination were observed in either group at each time point. Group 1 patients showed at day 30 a statistically significant amelioration of symptoms and reduction of HLA-DR expression. No changes in other parameters were detected. Group 2 patients showed at day 15 a statistically significant improvement of corneal and conjunctival stain versus baseline values and group 1 at the same time; after 30 days the symptoms score was statistically significantly better than baseline values and group 1 at the same time. The HLA-DR expression and the epithelial cells area were statistically significantly reduced versus baseline and group 1 at the same time.
Anti-inflammatory therapy is critical for the treatment of SS dry eye. Clobetasone butyrate, at low dosage, proved to be safe and effective in treating this condition.
Purpose: To investigate the intraocular pressure (IOP) reduction with prostaglandin analogs (PGAs)-timolol fixed combinations versus the unfixed combination of the same PGAs and timolol 0.1% in gel-forming carbomer.
Methods: Patients with primary open-angle glaucoma (POAG) receiving for at least 4 weeks the fixed combinations of PGA-timolol, administered once a day in the evening (0.005% latanoprost with 0.5% timolol, 0.004% travoprost with 0.5% timolol, 0.03% bimatoprost with 0.5% timolol) were switched to an unfixed combination of the same PGA (once a day in the evening) with timolol 0.1% in gel-forming carbomer (once a day in the morning) for at least 4 weeks. The primary endpoint was to compare efficacy of fixed vs unfixed combinations in lowering IOP. The effects of both regimens on short-term IOP fluctuations were also assessed.
Results: A total of 32 patients (64 eyes) fulfilled inclusion criteria: 17 patients received latanoprost-timolol fixed combination, 9 travoprost-timolol fixed combination, 6 bimatoprost-timolol fixed combination. For all considered time periods each unfixed combination induced an IOP reduction significantly higher than the corresponding fixed combination (paired t test: p<0.05 in all measurements). The diurnal IOP reduction was significantly higher during the unfixed combinations (p<0.001). Unfixed combinations significantly decreased IOP diurnal fluctuations and increased the percentage of patients with daily IOP fluctuation ≤2 mm Hg.
Conclusion: In this pilot study, PGA and timolol seems to be more effective in POAG treatment when administered as unfixed combinations, reducing both IOP and daily fluctuations. The once a day timolol 0.1% gel-forming carbomer may be a valuable option in PGA-timolol unfixed combination regimen.
To determine the intraocular penetration of topical drops of betaxolol HCl 0.25% suspension and betaxolol HCl 0.50% solution into the aqueous humor.
Fifteen patients were randomly assigned to receive topical betaxolol HCl 0.25% suspension (n=7) or topical betaxolol HCl 0.50% solution (n=8) the day before cataract surgery. Aqueous samples were collected 2 hours after the administration of the morning dose during cataract surgery. Drug concentrations were determined by high-performance liquid chromatography with fluorescence detection.
The mean aqueous humor concentration of topical betaxolol HCl 0.25% suspension was 275.1+/-168.8 micro g/mL (range 570-70 micro g/mL) and the mean aqueous humor concentration of topical betaxolol HCl 0.50% solution was 195.4+/-102.4 micro g/mL (range 334-50 micro g/mL) (p=0.281).
The mean aqueous humor concentration of betaxolol 0.25% suspension was higher than betaxolol 0.50% solution; however, the difference was not statistically significant. With twofold reduced concentration and similar anterior chamber penetration, betaxolol 0.25% suspension could be first choice for Beta 1 selective blocker therapy when considered for patients with glaucoma.
We conducted a double-masked, prospective study to evaluate the effect of 0.5% and 0.25% apraclonidine on postoperative intraocular pressure (IOP) in patients undergoing extracapsular cataract extraction (ECCE) with intraocular lens (IOL) implantation.
Fifty-four patients scheduled for ECCE were randomly divided into three groups of 18. The first group received one drop of 0.50% apraclonidine topically one hour before surgery and immediately after the end of the procedure. The second group received the same regimen but with 0.25% apraclonidine. The third group received artificial tears as the control group. IOP was measured 12 h preoperatively and 6 and 24 h postoperatively. All the measurements were made using the same Goldmann applanation tonometer by the same surgeon who did not know to which group the patient belonged.
Preoperative mean IOP was 13.66 +/- 2.76 mmHg in the first group, 14.27 +/- 2.24 mmHg in the second and 14.5 +/- 1.34 mmHg in the control group. The differences were not significant (p = 0.398). Mean IOP at the early postoperative visit (6 h) was significantly lower in the first group (17.44 +/- 4.95 mmHg) than the second (21.78 +/- 7.19 mmHg) and the control group (24.55 +/- 5.65 mmHg) (p < 0.001). Mean postoperative IOP at 24 h was again significantly lower in the first group (14.33 +/- 3.75 mmHg) than the second (17.11 +/- 4.16 mmHg) and the control group (19.61 +/- 3.20 mmHg) (p, 0.001).
Our findings indicate that topical 0.5% apraclonidine controlled early postoperative intraocular hypertension after cataract extraction without any side effects, while the 0.25% drops were not effective.
The efficacy and adverse effects of 0.25% apraclonidine on intraocular pressure (IOP) after Nd:YAG laser posterior capsulotomy were investigated, and the results were compared with placebo, 0.50% timolol maleate and 1% apraclonidine.
Eighty eyes were randomly assigned to four groups of 20 eyes. In a double-masked design, the groups were treated with placebo (group 1), 0.50% timolol maleate (group 2), 1% apraclonidine (group 3), 0.25% apraclonidine (group 4) one hour before and five minutes after Nd:YAG laser posterior capsulotomy. IOP was measured by applanation tonometry 1 hour before (baseline IOP) and 1, 3, 24 hours after capsulotomy.
The average baseline IOP increased respectively 3.90 +/- 5.35, 5.95 +/- 5.32, 1.15 +/- 3.20 mmHg in the first group 1, 3 and 24 hours post-treatment. There were significant differences between baseline IOP and 1 and 3 hours but not at 24 hours (p = 0.004, p = 0.001, p = 0.13). IOP increased 0.40 +/- 4.08, 0.75 +/- 5.33, 0.80 +/- 6.03 mmHg in the second group at the same times. The differences between the average baseline IOP and the 1, 3 and 24 h measurement were not significant (p = 0.83, p = 0.65, p = 0.93). In the third group, IOP decreased 3.70 +/- 2.40, 3.30 +/- 2.47, 2.65 +/- 1.56 mmHg at the measurement times, with significant differences between the average baseline IOP and the 1, 3 and 24 hour measurements (p = 0.001, p = 0.0001, p = 0.01). In the fourth group IOP increased 0.35 +/- 3.32 mmHg at 1 hour, but decreased 1.25 +/- 3.41, 0.90 +/- 2.07 mmHg at 3 and 24 hours. The differences were not significant (p = 0.94, p = 0.16, p = 0.08). When the 0.25% and 1% apraclonidine groups were compared, there were significant differences between the average IOP at 1 hour in both groups but not at 3 and 24 hours (p = 0.01, p = 0.17, p = 0.21). Similarly, there were no significant differences between the average IOP at the same times when the 0.25% apraclonidine group was compared with the timolol group (p = 0.30, p = 0.08, p = 0.16). Some systemic and local side effects were seen in the timolol and 1% apraclonidine groups, but none with 0.25% apraclonidine.
It was concluded that 0.25% apraclonidine is effective in preventing the early elevation of IOP after Nd:YAG laser posterior capsulotomy and may offer an alternative to 0.50% timolol maleate and 1% apraclonidine.
To compare the safety and efficacy of a new enhanced viscosity ophthalmic formulation of tobramycin, given twice daily (BID), with the existing four times daily (QID) treatment regimen in patients with acute bacterial conjunctivitis.
This was a 12-day, multicenter, observer-masked, randomized, parallel group study. Patients received one drop of tobramycin 0.3% (3 mg/mL) enhanced viscosity ophthalmic solution BID or tobramycin 0.3% (3 mg/mL) ophthalmic solution QID in the affected eyes for 7 days. The primary efficacy variable was the percentage of patients with sustained cure/presumed bacterial eradication based on clinical judgment at the test-of-cure visit (Day 12). Pretherapy bacterial isolates were obtained and tested for susceptibility to tobramycin by determination of minimum inhibitory concentrations (MIC).
A total of 276 patients were enrolled in the study and 203 of these were culture positive and attended all follow-up examinations. In this group, 98% of those treated with tobramycin enhanced viscosity ophthalmic solution and 99% of those treated with tobramycin 0.3% ophthalmic solution were categorized as having sustained cure/presumed eradication at the test-of-cure visit (p = 0.6037). Reported adverse events were not serious, mild to moderate in severity, and generally did not prevent continuation in the study. Several pre treatment pathogens demonstrated tobramycin resistance (MIC > 4 mg/mL). However, therapy with both treatments was effective in the majority of the cases.
Tobramycin enhanced viscosity ophthalmic solution is well tolerated and has equivalent efficacy to the established treatment regimen with a simplified posology. The formulation provides an alternative therapy for acute bacterial conjunctivitis that should improve patient compliance and satisfaction.
The main purpose of this prospective study was to compare the efficacy, local tolerance, and safety of topical lomefloxacin 0.3% and topical ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis.
Forty patients with acute bacterial conjunctivitis were included in a randomized, prospective, parallel-group study. Twenty patients were assigned to the lomefloxacin group (Okacin, CIBA Vision Ophthalmics) and 20 patients to ofloxacin (Oflox, Allergan). Lomefloxacin 0.3% was given 1 drop every 2 hours during waking hours on the first day then twice daily for one week. Ofloxacin 0.3% eyedrops were given four times daily. All patients underwent eye examination and clinical findings were graded and recorded according to severity of lid hyperemia, lid edema, lid crusting, conjunctival edema and discharge, bulbar conjunctival hyperemia, palpebral conjunctival hyperemia, corneal edema, and ocular discomfort. The score for each clinical sign was recorded before and after treatment. The mean cumulative sum score (CSS) was obtained by adding the scores for signs and symptoms. All conjunctival swabs were cultured and tested for sensitivity. Patients with confirmed bacterial conjunctivitis were included.
There were 10 male and 10 female patients in each group. The age range was from 1 to 78 years, and the mean age was 35 years in the lomefloxacin group. In the ofloxacin group the age range was from 1 to 70 years, and the mean age was 26 years. There was no significant difference between the two groups in relation to age or sex. The causative organisms were Staphylococcus epidermidis in 16 cases (36%), alpha-hemolytic Streptococci in 9 (20%), Haemophilus spp. 6 (13%), Staphylococcus aureus 5 (11%), Streptococcus pneumoniae 4 (9%), Pseudomonas aeruginosa 3 (7%), and other 2 (4%). The mean CSS for conjunctivitis was 12.1 before therapy in the lomefloxacin group and 12.7 in the ofloxacin group. On the 7th day of therapy, the mean CSS was 0.7 in the lomefloxacin group, and 1.6 for ofloxacin. All patients showed improvement, but a total of 18 out of 20 (88%) in the lomefloxacin group showed complete resolution compared to 15 (75%) in the ofloxacin group. The difference was not statistically significant (p = 0.08). Tolerance was excellent in both groups, and no side effects were reported. A burning sensation was noted by two patients, one in each group.
Lomefloxacin and ofloxacin were equally effective and safe in the treatment of acute bacterial conjunctivitis.
To evaluate the efficacy, safety, and tolerability of Timogel® preservative-free once daily compared to timolol 0.5% ophthalmic solution bid in patients with ocular hypertension (OHT) and patients with primary open-angle glaucoma (POAG).
A total of 75 patients with OHT and patients with POAG treated with timolol 0.5% bid with intraocular pressure (IOP) ≤ 21 mmHg were enrolled. They underwent complete ophthalmologic examination, IOP measurements (at trough and daytime curve), evaluation of side effects, Schirmer test, break-up time [BUT], blood pressure, heart rate, ocular diastolic perfusion pressure measurements, and acceptance (Comparison of Ophthalmic Medications for Tolerability). Patients switched to Timogel® and were re-evaluated 3 months later. The analysis of variance and the Pearson Chi2 tests were used to test differences between the treatments.
Intraocular pressure reduction at trough was 23.6% with timolol 0.5% and 22.3% with Timogel®. No statistical differences were observed in IOP values at trough and in the daytime curve between the 2 treatments. Local and systemic side effects were less frequent with Timogel® (hazard ratio: p<0.05). Patients demonstrated a significant improvement of Schirmer test and BUT (p<0.05) and a reduction of dryness and foreign body sensation (42.6% vs 15.4%; p<0.01) after switching to Timogel®. Mild and short-lasting blurred vision after Timogel® instillation occurred in about 18.5% of patients. A total of 82% of patients were satisfied or very satisfied with Timogel® vs 61% with previous treatment (p<0.01).
Timogel® preservative-free dosed once every morning has a 24-hour hypotensive effect with a better safety profile than timolol 0.5% bid and it is well-accepted by patients. The once-daily dosing improved acceptance and compliance.
Retinopathy of prematurity (ROP) is a leading cause of visual loss in infancy that is largely preventable with careful screening. We report the safety and efficacy of the use of phenylephrine 2.5% and cyclopentolate 0.5% eyedrops instilled 3 times 5 minutes apart in ROP screening.
A total of 1246 ROP screening eye examinations were carried out by the same pediatric ophthalmologist between February 2011 and May 2013. Outcome measures were successful mydriasis (defined as achieving a full screening examination) and any intraprocedural systemic complications (defined as any respiratory, cardiac, or other clinical deterioration severe enough to result in screening abandonment).
Of 1246 eyes, 1234 (98.8%) achieved successful dilation to enable complete screening. A fourth application was successful in the remaining 1.2%. No respiratory or cardiac arrest or any other intraprocedural event requiring cessation of screening was encountered during any of the examinations. No retinal bleeding or other intraocular complication occurred.
This is the largest cohort studying the effectiveness and safety of a mydriatic regimen for ROP screening. We have found the combination of phenylephrine 2.5% with cyclopentolate 0.5% to be efficacious and well-tolerated. The absence of any severe intraprocedural complications may be related to reduced indentation time and stress in the infant facilitated by effective pupil dilation.
To evaluate azithromycin tear concentrations after one drop of T1225 0.5%, 1.0%, and 1.5% eyedrops.
In this randomized, double-masked study, 91 healthy volunteers received one drop into each eye of T1225 0.5% (n=23), T1225 1.0% (n=38), or T1225 1.5% (n=38). Azithromycin tear concentrations were measured by HPLC-MS at seven time points for 24 hours. Tolerability was evaluated.
T1225 1.0% and 1.5% had similar pharmacokinetic profiles. After a post-instillation peak (167 to 178 mg/L after 10 minutes), mean concentrations remained above 7 mg/L for 24 hours (except for T1225 1% at H24). A delayed increase of the azithromycin mean tear concentration might be explained by the known late azithromycin release from tissues after storage in cells. Areas under inhibitory curve (AUICs) of T1225 1.0% and 1.5% were higher than AUICs of T1225 0.5% and ranged between 47 and 90. The three T1225 concentrations were safe for the ocular surface.
Once daily instillation of T1225 1.0% and 1.5% was shown to reach an AUIC markedly above the required threshold for an antibacterial activity against Gram-positive bacteria (25-35). These results suggest that a BID instillation is more likely to ensure antimicrobial activity against Gram-negative bacteria (threshold >100).
The authors compared the efficacy of local anesthetics levobupivacaine, bupivacaine, and lidocaine for retrobulbar anesthesia in vitreoretinal surgery.
A total of 135 patients presenting for vitreoretinal surgery under local anesthesia were included in the study. Patients were randomly allocated to one of three groups. Group LB patients received 5 mL of 0.5% levobupivacaine, Group L patients received 5 mL of 2% lidocaine, and Group B patients received 5 mL of 0.5% bupivacaine for retrobulbar anesthesia via inferotemporal injection. Sensory and motor block durations were recorded. Intraoperative and postoperative pain was assessed by using verbal pain scala. Anesthesia efficiency, patient and surgeon satisfaction, and akinesia were assessed by using point scales. Hemodynamic data and adverse events were recorded.
The demographic characteristics of patients, duration of surgery, and hemodynamic data in both groups were similar. The duration of motor and sensory block was longer in levobupivacaine and bupivacaine groups than lidocaine group. Pain on injection was found more frequent in Group L and Group B than Group LB and the difference between the Groups LB and B was significant (p<0.05). Surgeon and patient satisfaction were also higher and intraoperative pain was less in levobupivacaine group than lidocaine and bupivacaine groups.
Levobupivacaine provides longer motor and sensory block duration and higher surgeon and patient satisfaction than lidocaine and bupivacaine when used for retrobulbar anesthesia in vitreoretinal surgery.
To evaluate with color Doppler imaging (CDI), in patients with primary open-angle glaucoma (PDAG), the possible influence on ocular hemodynamics of a beta-blocking agent with intrinsic sympathomimetic acitivity (carteolol 2%) compared to a beta-blocker agent without this activity.
A study was carried out on 20 patients, with bilateral POaG, intraocular pressure (IOP) < or = 20 mmHg, all treated twice a day with timolol maleate 0.5% ophthalmic solution. The visual field was evaluated (Octopus 2000 perimeter, G1 program) examining the mean sensitivity (MS) and the mean defect (MD). CDI was carried out to evaluate the resistance index of the internal carotid artery (ICA), the ophthalmic artery (OA), the central retinal artery (CRA), and the short posterior ciliary arteries (SPCA). After these examinations, the therapy was changed to carteolol 2% twice a day. After six months of treatment the examinations were repeated. The data were analysed statistically using Student's t test.
The mean intraocular pressure during treatment with timolol 0.5% was 16.7 +/- 1.67 mmHg and 16.33 +/- 1.72 mmHg after treatment with carteolol 2%, the difference not being significant (p=0.494). After six months of treatment with carteolol 2% the MS increased significantly from 22.4 +/- 2.5 dB to 24.1 +/- 1.8 dB (p=0.018), and the mean defect (MD) fell from 5.3 +/- 0.8 dB to 4.7 +/- 0.6 dB (p=0.011). There was no significant difference in the resistance index of the CA, the OA and the CRA with the two treatments, whereas the resistance index of the SPCA dropped significantly, from 0.80 +/- 0.05 to 0.77 +/- 0.02 (p = 0.017).
CDI did not show significant differences in the resistance indexes of the internal CA, the OA, and the CRA after treatment with carteolol 2% but the resistance index of the SPCA was significantly reduced. Carteolol 2% induced significant changes in the perimetric indexes examined, with an increase in MS and a decrease in MD. These findings suggest that the intrinsic sympathomimetic activity of carteolol may reduce peripheral vascular resistance of the SCA, thus improving perfusion of the optic nerve head, with a protective effect on visual function.
To describe the results obtained in patients with neovascular age-related macular degeneration treated with ranibizumab 0.5 mg on an as-needed basis from the start after 1 year of follow-up.
Retrospective, consecutive interventional case series of patients with all angiographic types of neovascular age-related macular degeneration (mean baseline size, 3.4 disk areas) in a tertiary retinal center (Institut de la Màcula i la Retina; Barcelona, Spain). Main outcome was mean vision change; secondary outcomes were center retinal thickness change, number of injections, adverse events, and independent covariates associated with a good response.
Mean visual acuity change was an increase of 1.3 letters (95% confidence interval -2.7 to +5.3), and difference between angiographic patterns did not reach statistical significance (p=0.30). A decrease in retinal thickness of 44.6 µm was identified (p<0.001), with a median of 3 injections. Absence of baseline arterial hypertension, lower visual acuity, and lesions located outside the fovea were associated with a better response to therapy.
As-needed treatment from the start achieved stabilization of visual acuity and a moderate decrease of retinal thickness with a low number of injections, but did not achieve the same efficacy as regular monthly injections.
A prospective, double masked, randomised study was performed to compare the speed of onset of peribulbar anaesthesia using pH adjusted 0.75% bupivacaine, with and without the addition of hyaluronidase. No significant difference in speed of onset occurred due to the addition of hyaluronidase. There were 7 cases of post operative ptosis in the study group, including 1 case of orbital apex syndrome and 2 cases of transient 3rd nerve palsy. This incidence of post operative ptosis using pH adjusted 0.75% bupivacaine was statistically significantly greater than in a matched control group who received a 50:50 mixture of 1% lignocaine and 0.5% bupivacaine with hyaluronidase (p < 0.05). The possible causes of this increased incidence of post operative ptosis are discussed.
To evaluate if topical bupivacaine 0.75% provides better pain control after excimer laser over topical tetracaine 1% without affecting corneal wound healing, refractive outcome of visual function.
A prospective, double-masked trial was conducted in which 38 patients were randomized to receive either tetracaine or bupivacaine every 30 minutes for 24 hours post-operatively. Pain was recorded over a four day period using a Visual Analogue Pain Scale. The rate of epithelial healing was assessed during digitized retro-illumination photography. Visual performance was recorded using best corrected Snellen acuity, objective measurements of haze, halo and glare over a six month period.
Tetracaine afforded better pain control (p = 0.05). Full epithelial closure occurred in all patients within 72 hours and no statistically significant difference was recorded in any of the parameters measured.
Contrary to our expectation, the longer acting anaesthetic, bupivacaine, was inferior to tetracaine. Limited and supervised use of topical anaesthetics is recommended in controlling pain following photorefractive keratectomy.
This study aimed to compare intraocular pressure (IOP) measurements obtained by the transpalpebral tonometer TGDc-01 and by the Goldmann applanation tonometer (GAT).
IOP was measured by the conventional GAT and the TGDc-01 tonometer. Central corneal thickness (CCT) was measured for all eyes.
Sixty-seven consecutive patients (123 eyes) participated. The mean difference between the 2 techniques (TGDc-01-GAT) was -0.93 mmHg, SD=2.74 (p=0.0002, paired t-test), and 70% of the measurements were within +/-2 mmHg. The correlation coefficient was 0.67 (p<0.0001). A subgroup analysis according to CCT was conducted. For CCT <520 microm, the mean IOP difference was 0.67 mmHg (p=0.13); r=0.75 (p<0.001). For CCT 520 microm-580 microm, the mean IOP difference was -1.08 mmHg (p=0.001); r=0.69 (p<0.0001). For CCT>580 microm, the mean IOP difference was -2.29 mmHg (p=0.0003); r=0.57 (p=0.003).
TGDc-01 may estimate IOP with a fair agreement to the Goldmann tonometer, although caution should be used for patients who require precise IOP measurements. TGDc-01 measured higher IOPs than Goldman tonometry for thinner corneas, a trend that was reversed for thicker corneas. This tonometer is a portable device, easy to use, does not require anesthetic drops, and may be suitable for IOP screening.
Antibacterial efficacy of topically applied azithromycin 1.5% was compared with tobramycin 0.3% in a multicenter, randomized, investigator-masked study for the treatment of purulent bacterial conjunctivitis.
A total of 1043 adults and children received either azithromycin twice daily for 3 days (n=524) or tobramycin every 2 hours while awake for 2 days, then four times daily for 5 days (n=519). Conjunctival swabbing was taken at days 0, 3, and 9, using alginate swabs resuspended in a dissolution-transport medium, providing rapid and reproducible results. Cagle's criteria were used to define the pathogenicity level for each isolated bacterium.
In the per-protocol set, the rate of bacteriologic resolution was 85.2% for azithromycin versus 83.8% for tobramycin on day 3, and 92.8% for azithromycin versus 94.6% for tobramycin on day 9. Azithromycin was demonstrated to be noninferior to tobramycin according to the 10% noninferiority margin. Although some bacteria were categorized as resistant to tested antibiotics, eradication was observed (for azithromycin: Acinetobacter, Enterobacteriaceae, Pseudomonas), highlighting the specific pharmacokinetics/pharmacodynamics of the ocular route.
In total, topical therapy with azithromycin 1.5% administered only twice daily for 3 days effectively eradicates most pathogenic bacteria associated with bacterial conjunctivitis. These microbiologic results are in accordance with the observed clinical outcome. This new anti-infective product has the advantage of a short treatment course which could lead to an improvement in patient compliance.
The study examined the influence of individual blood pressure changes overtime on retinal vessel diameter and the latter's response to flicker light.
The diameter of a retinal arterial and venous segment was measured continuously on-line with a Dynamic Vessel Analyzer in 20 patients twice (mean interval between examinations of 24 months). Eleven patients had no cardiovascular disease. Nine patients had arterial hypertension and were untreated at the time of the first measurement; at the time of the second measurement they were undergoing various antihypertensive therapies. Each test consisted of a 50-s baseline plus three 20-s periods of flicker stimulation followed by an 80-s period of observation. During the examinations the blood pressure was measured at 1-minute intervals.
In the hypertension group changes in the mean arterial blood pressure (MAP) correlated significantly with changes in the arterial baseline diameter (y = -0.1 - 0.37x, r =0.74, p (increase) <0.03). A comparison of the two measurements showed no such relationship in the group of cardiovascularly healthy subjects. The venous baseline and the arterial and venous flicker response did not change significantly in either group between the two measurements and showed no relationship to blood pressure changes.
In hypertensive subjects, long-term therapy-related changes in blood pressure induced a change in the arterial baseline by approximately +3.7 microm/-10 mmHg MAP. An influence of lowering MAP to the arterial flicker response could not be detected.
Ophthalmic emergency (OE) triage is essential for prompt recognition of urgent cases. To date, no formal eye-dedicated triaging system has been widely accepted. The purpose of the present study is to propose a fast, accurate, and reproducible coding scale called the Rome Eye System for Scoring Urgency and Emergency (Rescue).
Phase 1 of the study is a retrospective analysis of electronic medical records (EMR); phase 2 is a prospective consecutive series. Phase 1 included 160,936 patients. Phase 2 included 1000 consecutive patients referred to the emergency department (ED) of our institution. In phase 1, the authors retrospectively analyzed EMRs of patients presenting to the ED, listing signs and symptoms most frequently associated with hospitalization. Redness, pain, loss of vision, and the risk for an open eye were identified and assigned a score ranging from 0 to 12. Color coding was assigned based on increasing scoring: 0-3 white, 4-7 green, 8-12 yellow code. In phase 2, 1000 consecutive ED patients were enrolled and prospectively coded according to RESCUE. After diagnosis and proper treatment, EMRs were retrospectively reviewed by a masked physician and patients recoded (Retro coding) according to clinical course. Correlation between Rescue and Retro coding was calculated. Main outcome measures: Prospective and retrospective ED color coding correlation.
A total of 160,936 EMR were retrospectively analyzed; 2407 (1.4%) patients required hospitalization. Loss of vision (90%), redness (76%), and pain (47%) were the most frequent complaints. Rescue significantly correlated to Retro coding (p<0.01): 841/1000 patients coded exactly the same color, 45/1000 were overestimated by one color class, none by two, 107/1000 underestimated by one, and 6/1000 by two classes. The 32/1000 hospitalized patients in the prospective cohort had a Rescue score significantly higher than non-admitted patients (p<0.01) and color coding among admitted and dismissed patients was significantly different as well (p<0.01).
To compare the results of advanced visual field defects (VFD) measured with the conventional reference perimeter Octopus 101 (O-101) and the new portable Tübingen Mobile Campimeter (TMC).
Thirty-seven subjects (18 to 75 years), 13 with advanced arcuate scotomas, 12 with VFD respecting vertical meridians, 6 with concentric constriction and 6 healthy controls were included. First examination was with O-101: grid 30 degrees -NO, 192 stimuli, 10 cd/m(2) background luminance, stimulus size: Goldmann III (26'); second examination was with TMC: 84 stimuli (subset of grid 30 degrees -NO), stimulus size 34', stimulus luminance 320-370 cd/m(2), background luminance 8-20 cd/m(2). Pointwise accuracy (proportion of concordant locations), sensitivity, and specificity were estimated into 95% confidence intervals (CI) by averaging individual logits. Examination durations were compared.
TMC results are highly concordant with O-101 results for all defect classes. For the entire sample, the percentage of discordant points (perceived with TMC but not with O-101) among all discordant points was 35% (CI: 30% to 40%). Analyzed by VFD pattern, accuracy was highest in healthy controls scotomas (97.9%; CI: 97% to 98.5%) and lowest in arcuate scotomas (80.6 %; CI: 77.3% to 83.5%). Sensitivity was highest in concentric constriction (94.5%; CI: 82.9% to 98.4%) and lowest in healthy controls (59.1%; CI: 26.3% to 85.3%). Specificity was highest in healthy controls (98.1%; CI: 96.6% to 98.9%) and lowest in concentric constriction (77.4%; CI: 62.1% to 87.7%). Mean examination time was 4.6 minutes (TMC) and 9.8 minutes (O-101).
The results indicate that the TMC is a feasible device for detection of VFD.
We conducted a nation-wide study of the relationship of myopia with height, weight and body-mass index in order to confirm observations that myopic persons are taller than non-myopes. From a review of the data of 106,926, consecutive male military recruits aged 17 to 19 years, we found that myopia is associated neither with higher stature nor with greater weight. Persons with severe myopia were slightly shorter (172.8 +/- 7.1 cm) and weighed less (62.6 +/- 11.0 kg) than those with mild myopia (173.3 +/- 6.9 cm and 63.8 +/- 10.5 kg respectively), while the non-myopes were taller (173.7 +/- 6.7 cm) and heavier (63.9 +/- 10.2 kg) than the myopes (p = 0.0001). The mean body-mass index was only slightly smaller among the myopes (21.1 +/- 3.1 kg/m2) than among the non-myopes (21.2 +/- 2.9 kg/m2, p = 0.0001).
A retrospective study was conducted to evaluate the risk of increased intraocular pressure (IOP) following a temporary silicone oil (SO) tamponade and to study some parameters possibly involved in this hypertension.
Forty-four patients with retinal detachment complicated by proliferative vitreoretinopathy (PVR) were treated by vitreoretinal surgery and SO tamponade. One to 11 years after SO removal, they underwent full ophthalmic examination. All these patients had a healthy, non-operated, normotensive fellow eye.
Six (14%) of 44 eyes had IOP higher than 20 mmHg. Five other eyes (11%) had their IOP controlled by beta blockers. Phakic and pseudophakic eyes had a very limited tendency to develop ocular hypertension and anyway responded well to beta blockers. Residual SO droplets in the eye after removal of the big bubble of SO disappeared exponentially with a mean disappearance time of three years. Eyes with residual SO were no more prone to ocular hypertension than those without (p > 0.50). No association was found between IOP and duration of SO tamponade (r = 0.13) or between IOP and flare (r = 0.14).
This study suggests that the risk of developing ocular hypertension after a temporary SO tamponade is moderate. No satisfactory explanation could be found for this increase of IOP.
To assess the incidence of extrusion and infections of encircling silicone sponges in scleral buckling surgery for retinal detachment with and without the use of an intraoperative antibiotic soaking procedure.
The authors performed a retrospective analysis reviewing the charts of 1127 patients who underwent episcleral buckling surgery operated by the same surgeon in three different institutions during a period of 11 years. The authors reviewed the charts of patients treated with a single episcleral silicone sponge (Labtician) indentation in three different models. The infection prophylaxis on the operating field was the same in all cases and only since February 1997 was the silicone sponge preoperatively treated with an antibiotic soaking procedure.
No immediate postoperative infections were reported in the operated eyes. Three eyes had an implant extrusion and in all these cases silicone sponge removal was performed. All three extrusion cases developed when sponge soaking was not adopted.
The data indicate that the soaking procedure does not decrease extrusion and infection incidence in scleral buckling surgery when both accurate surgical technique and disinfection prophylaxis are performed.
To report a case of presumed bilateral acute retinal necrosis with delayed onset caused by herpes simplex virus type 2, medical treatment, and surgical approach.
Retrospective, interventional case described in a 51-year-old patient who complained of unilateral blurred vision with history of nonoperated retinal detachment in his fellow eye after posterior uveitis 11 years earlier.
Ocular examination suggested diagnosis of acute retinal necrosis involving the posterior pole and sparing periphery. The causative agent was demonstrated using polymerase chain reaction analysis of the aqueous humor. Intensive medical treatment with intravenous acyclovir, intravitreous foscarnet, and corticosteroids was administered, slowing down but not stopping progression of the disease. Due to the monocular status of the patient and high probability of secondary retinal detachment, early vitrectomy was indicated.
Rapid and aggressive medical treatment is necessary in this condition. Bilateral involvement often occurs within weeks, but can also happen more rarely after several months or years, requiring long-term follow-up. Early surgical treatment is controversial but it is an option to be considered in certain cases.
Purpose: To analyze the outcome and risk factors of recurrence in patients with basal cell carcinomas (BCCs) of the eyelid treated by en face frozen section-controlled (FSC) excision with a mean follow-up over 5 years.
Methods: This was a retrospective series of 108 patients with 110 biopsy-proven eyelid BCCs. All lesions were excised with 2 mm margins clinically free from neoplasia at clinical examination. For each tumor, en face frozen section examination of surgical margins was employed for the histologic confirmation before the reconstruction. Subsequently, all margins were submitted for permanent paraffin sections.
Results: Of 110 malignancies, 80.9% represented primary carcinomas and 19.1% secondary ones. The overall recurrence rate was 1.8%, with a mean follow-up of 72.4 months (range 30-167). The mean time between the excision of the lesion and the diagnosis of the recurrence was 24 months (range 20-28). No recurrences were observed in 62 tumors followed up for at least 5 years. Secondary BCCs were associated with a higher recurrence rate compared with primary BCCs (4.8% and 1.1%, respectively, p = 0.262).
Conclusions: The FSC excision of eyelid BCCs yields recurrence rates comparable to those of Mohs micrographic surgery at 5-year follow-up. Intraoperative microscopic margin control improves the cure rate of eyelid BCCs, and FSC excision with small margins (2 mm) clinically free from neoplasia is associated with easier reconstruction and better cosmetic and functional outcomes.
Panphotocoagulation reduces the risk of vision loss in proliferative diabetic retinopathy. However, not many patients tolerate this treatment well due to pain. Therefore, we evaluated the analgesic effect of etoricoxib during photocoagulation in patients with proliferative diabetic retinopathy.
A prospective, randomized, double-blind study was conducted on 44 consecutive patients eligible for panphotocoagulation due to proliferative diabetic retinopathy. During the first panphotocoagulation session, both groups were treated without medication. During the following session, the control group received a placebo pill while the other group received etoricoxib 120 mg. Both groups took the medicines 1 hour before the treatment. After each session, the patients quantified the level of pain on a subjective visual scale.
A total of 52 patients were selected for the study and the data of 44 patients were analyzed. In the control group, the average level of pain in the first session was 7.68 (standard deviation 1.70), dropping to an average of 7.32 (standard deviation 1.39) after ingestion of placebo. Therefore, there was no statistical difference (p = 0.1187). In contrast, the average level of pain without the drug in the group taking etoricoxib 120 mg was 7.95 (standard deviation 1.46) vs 5.18 (standard deviation 1.65) with the drug, a significant statistical difference (p<0.001).
Etoricoxib 120 mg reduces pain and can be used before panphotocoagulation. Data show that the medication is more effective against pain during photocoagulation than placebo.
To examine the efficacy of monthly injections of intravitreal bevacizumab (IVB) for macular edema after iodine-125 plaque radiotherapy of uveal melanoma.
We studied 36 patients with macular edema after plaque radiotherapy of uveal melanoma in this noncomparative, interventional case series. All eyes were treated with 4 monthly injections of IVB. Central macular thickness (CMT) and best-corrected visual acuity (BCVA) were measured before each injection and 4-6 months after the first injection. The main outcome measures were change in CMT and BCVA.
At 4-6 months following the first IVB, 20 eyes (56%) had decreased CMT, 11 eyes (31%) had stable CMT, and 5 eyes (14%) had increased CMT. The mean change in CMT and the mean percent change in CMT at 4-6 months compared to baseline were -91 µm (-20%) in all eyes, -174 µm (-37%) in the group with decreased macular thickness, -14 µm (-3%) in the group with stable macular thickness, and +69 µm (+17%) in the group with increased macular thickness. At 4-6 months, 15 eyes (42%) had increased BCVA, 16 eyes (44%) had stable BCVA, and 5 eyes (14%) had decreased BCVA. An increase in CMT was seen between the fourth monthly IVB injection and the final evaluation at 4-6 months after the first injection in all 3 groups of our study.
At 4-6 months following the first injection, 4 monthly injections of IVB in eyes with macular edema after plaque radiotherapy of uveal melanoma decreased macular edema in 56% and improved BCVA in 42% of the treated eyes.
We report a prospective study of 19 choroidal melanomas treated with iodine-125 plaque from 1984 to 1989. The mean tumor height was 5.8 mm, base diameter 11.6 mm, and tumor volume 80 to 510 mm3. The mean radiation dose to tumor apex was 70 Gy and scleral contact dose 355 Gy; tumor base was surrounded by contiguous laser or cryopexy lesions. Follow-up was 27 to 84 months (mean 60 months). All tumors regressed at least 50% in volume with no tumor regrowth within 27 months to 60 months. Late tumor regrowth, localized in the center, occurred in one eye after 65 and another after 69 months. One tumor was successfully replaqued; the other was not re-treated because the patient had had a recent heart attack. In 17 eyes radiation retinopathy developed after 1 1/2 years, the earliest in a diabetic eye. Despite primary recovery of preoperative vision, there was severe deterioration of visual acuity after 4 1/2 years in all the eyes. During follow-up, two patients died due to metastases after 28 and 71 months; one patient is alive with metastases after 17 months. None of the eyes had to be enucleated. There was no incidence of madaurosis, symblepharon, or dry eye.
The authors wondered whether the spectrum of endophthalmitis and the type of therapy had changed.
Files of patients who were operated upon for endophthalmitis between 1988 and 2000 were retrospectively analyzed. They were divided into Group 1 (operated upon 1988 to 1994) and Group 2 (1995 to 2000).
Group 1 consisted of 83 patients (43.4% female, mean age 63.9 years), Group 2 of 108 (38.9% female, mean age 64.6 years). Bilateral endophthalmitis occurred in 8.4% of Group 1 patients (3.7% of Group 2 patients). Patients in both groups took on average 1.2 drug types against various internal diseases. The mean interval between first symptoms and presentation in the clinic was 45.7 days in Group 1 (19 days in Group 2; difference statistically significant). There were 63% (Group 1) (70% [Group 2]) cases of postoperative endophthalmitis, among them 58% (Group 1) (63% [Group 2]) after cataract extraction, 6% (Group 1) (5% [Group 2]) after glaucoma surgery, 20% (Group 1) (17% [Group 2]) endogenous and 17% (Group 1) (13% [Group 2]) post traumatic. In Group 2 slightly more Gram-negative bacteria were found. As an initial procedure the following were performed: vitrectomy (70% [Group 1], 88% [Group 2]), removal of crystalline lens (11% [Group 1], 10% [Group 2]), removal of pseudophakos (2% [Group 1], 12% [Group 2]), opening of posterior capsule (1% [Group 1], 9% [Group 2]), and anterior chamber irrigation (36% [Group 1], 43% [Group 2]), often combining procedures. There were significantly more vitrectomies and openings of the posterior capsule in Group 2. Neither the spectrum of secondary and tertiary procedures nor the reasons for such surgery differed in both groups. Neither visual acuity at initial presentation (0.1) nor at final follow-up (0.3) differed between the two groups. The rate of enucleation was less in Group 2 (6% versus 11%) although not statistically significantly.
In Group 2 there were slightly more Gram-negative bacteria and the time interval between initial symptoms and presentation in the clinic had decreased. This can be interpreted as an increase in the severity of the endophthalmitis cases. The final visual acuity was identical in both groups, the enucleation rate improved.
To report changes in retinal nerve fiber layer (RNFL) thickness in a patient with neuromyelitis optica (NMO).
A 13-year-old Caucasian boy presented with reduced visual acuity in both eyes, headache, and neck pain associated with left hand burning sensation. Clinical and laboratory examination, including magnetic resonance imaging (MRI) and optical coherence tomography (OCT), were performed.
MRI showed spinal cord abnormality and acute myelitis, but normal optic nerve head. A significant reduction of the average and temporal area RNFL thickness was recorded in both eyes by OCT. Six months after initial steroid treatment, visual acuity and visual field slightly improved, but RNFL thickness was further reduced.
RNFL thickness measurement with OCT should be performed not only in adults, but also in young patients in case of suspected NMO to confirm the diagnosis and to monitor the disease.
To analyze the anatomic and functional consequences of wine-cork injury to the eye in relation to the patient's age and the type of cork and wine.
We retrospectively studied 13 patients, six women and seven men, presenting to our department with bottle-cork injury to the eye between January 1999 and June 2001.
All patients presented with closed-globe injury according to Kuhn et al's classification. All the cases were injured by bottle corks from sparkling wine: white in ten cases and red in three. Mean visual acuity at admission was 20/100 (range, hand motion to 20/20). The most frequent early injury was anterior chamber hyphema (84.6%), followed by corneal injury (62.2%), ocular hypertension (46.1%), lens subluxation (30.8%), traumatic cataract (23.1%), and post-traumatic retinal edema (23.1%). Mean final visual acuity was 20/25; the follow-up ranged from 3 to 29 months, averaging 16.1 months. Late complications were as follows: pupil motility anomalies (38.5%), traumatic cataract (30.8%), iridodialysis (15.4%), traumatic optic neuropathy (7.7%), post-traumatic glaucoma (7.7%), and traumatic maculopathy (15.4%). Surgical treatment was necessary in two cases (15.4%).
Bottle-cork eye injuries account for 10.8% of post-traumatic hospital admissions to our department. Most of them are due to sparkling white wine served at room temperature. There is no correlation between ocular injury and the eye-bottle distance or the type of cork.
To discuss the anatomical and functional results in cases of optic disc pit maculopathy (ODP-M) with a follow-up of at least 11 years after scleral buckling procedure (SBP).
We studied 12 eyes with ODP-M treated with SBP, in a long-term follow-up of 12.8 ± 1.5 years after surgery. All patients underwent best-corrected visual acuity (BCVA) measurement, slit-lamp biomicroscopy, fundus photography, fluorescein angiography, indocyanine green angiography, B-scan ultrasonography, and optical coherence tomography at baseline and 6-12 months, 2 years and at least 11 years postoperatively.
Complete macular reattachment was noticed between 6 and 12 months postoperatively. The BCVA improved significantly at the first postoperative examination. Further improvement was noticed at the second examination, while BCVA remained almost stable at the last examination. Foveal restoration of ellipsoid layer (inner segment/outer segment) was noted in 10 out of 12 cases. The existing vitreous strands remained unchanged during the follow-up. Vitreous traction gradually disappeared (4/5 eyes). Circulation in short/long posterior ciliary arteries was unaffected, while neither recurrences nor complications were observed during the follow-up period. Association of the scleral sponge to the scleral sheath of the optic nerve remained unchanged during the follow-up.
A total of 12.8 ± 1.5 years after treatment, all the studied cases retained the successful anatomical and functional results that they had 2 years postoperatively, without inducing cataract during the follow-up period. The SBP seems to act equally well as a barrier either obstructing the entrance of fluid from the vitreous cavity or blocking the circulation of subarachnoid cerebrospinal fluid into the retina.
A major complication of allogenic bone marrow transplantation (BMT) is graft-versus-host disease (GVHD), characterized principally by involvement of the eyes, producing a Sjögren-like syndrome (SLS). This study assessed the predictive role of the eye involvement in the onset of GVHD.
Thirty-five patients transplanted for hematological malignancies were routinely examined for ocular manifestation of dry eye. Examination includes the Schirmer I test, break-up time, Lissamine Green staining, fluorescein test, lactoferrin test and impression cytology. A threshold was established for quantitative analysis of SLS.
Fifteen of 35 patients (40%) developed SLS during long-term follow-up. Ten of these (77%) developed acute or chronic GVHD.
The possible etiology of SLS includes three factors: total body irradiation, ocular toxicity of chemotherapy and GVHD. A correlation was found between poor-prognosis GVHD and the occurrence of SLS.
To analyze and compare higher-order aberrations (HOAs) in cases of laser in situ keratomileusis (LASIK) flaps made using the Moria M2 disposable 130-micronm head with those made using the 90-micronm head.
Consecutive prospective comparative clinical trial. Ninety-four consecutive eyes of 48 patients were enrolled in this study. They were divided into two equal groups of 47 eyes that underwent wavefront-guided LASIK using VISX CustomVue (VISX, Santa Clara, CA) system. Corneal flap was created using the disposable Moria M2 130 micronm in the first group and the 90 micronm head in the second one. All patients were followed up for 6 months. Wavefront aberrations were measured at baseline, 1 month, and 6 months after surgery using the WaveScan (VISX Inc.) aberrometer. Root mean square (RMS) of HOAs, coma, and spherical aberration (SA) values were analyzed and compared in the two groups.
At 6 months, values of RMS of HOAs, coma, and SA obtained from the 130-micronm head group were 0.32+/-0.10 micronm, 0.20+/-0.11 micronm, and 0.18+/-0.08 micronm, respectively. Values of RMS of HOAs, coma, and SA obtained from 90-micronm head group were 0.33+/-0.12 micronm, 0.19+/-0.10 micronm, and 0.15+/-0.08 micronm, respectively. Analyzing the data obtained revealed no statistically significant differences between the two groups. In each group, there was a significant decay of higher-order RMS and coma values from 1 month to 6 months.
HOAs following use of Moria M2 disposable 90 micronm head are similar to those arising following use of the 130 micronm.