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ABSTRACT: PURPOSE: Recent use of a titanium (Ti) backplate has improved the design and biocompatibility of the Boston Keratoprosthesis (BKpro). Titanium's shiny metallic appearance, however, makes the cosmetic outcome less favorable. The purpose of this study was to develop and test a coloring surface modification of Ti. METHOD: Ti coloring was achieved using electrochemical anodization. Color assessment included: scanning electron microscopy (SEM), atomic force microscopy (AFM), X-ray diffraction crystallography (XRD), and Fourier transform infrared spectroscopy (FTIR). Biocompatibility assessment of Ti disks included: in vitro proliferation and cytotoxicity in co-culture with human corneal limbal epithelial cells (HCLE), primary human corneal fibroblasts and immortalized human corneal endothelial cells (HCEnCs) and in vivo intralamellar implantation in rabbit corneas. Histologic appearance (H&E and trichrome staining) and presence of cell inflammation (CD45), apoptosis (TUNEL) and corneal neovascularization (CD31) was evaluated 27 and 53 days post implantation. RESULTS: Blue and brown coloration of Ti was achieved. Analysis showed the presence of a nanoporous oxide surface with no chemical change of the modified Ti surface. In vitro assessment showed no significant differences in cell proliferation and cytotoxicity between anodized and non-anodized Ti (p> 0.05; ANOVA for all cell types). Analysis of corneal tissues harboring the Ti disks showed normal cellular appearance, and lack of CD45, TUNEL and CD31 positive cells. CONCLUSION: A biocompatible Ti backplate coloring was achieved by electrochemical anodization. In vitro and in vivo results suggest that the anodized Ti is equally biocompatible and as safe as the standard non-anodized Ti. The color modification of the BKpro may improve the cosmesis and acceptance of the BKpro by patients.
Investigative ophthalmology & visual science 05/2013; · 3.43 Impact Factor
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ABSTRACT: PURPOSE:: To evaluate the use of the Boston keratoprosthesis type I implantation in patients with mucous membrane pemphigoid (MMP). METHODS:: Retrospective review of 8 eyes of 8 patients with severe ocular surface disease and corneal blindness as a result of MMP who underwent Boston keratoprosthesis type I implantation at the Massachusetts Eye and Ear Infirmary from January 1, 2000, through December 31, 2009. The main outcome measures were best-corrected visual acuity, keratoprosthesis retention, and postoperative complications. RESULTS:: The mean age of patients was 71.3 years (range, 55-94 years), and the mean duration of their disease preoperatively was 6.1 years (range, 1.7-11.4 years). Visual acuity after the surgery improved to 20/200 or better in 6 eyes (75%) and to 20/40 or better in 3 eyes (37.5%). Only 1 of 6 eyes (16.7%) was able to maintain visual acuity of 20/200 or better over a mean follow-up period of 3.2 years. Five of the 8 Boston keratoprosthesis type I devices (62.5%) extruded or had to be replaced during a mean follow-up time of 1.7 ± 1.7 years. Loss of vision to worse than 20/200 during the follow-up period occurred because of keratoprosthesis type I extrusion, end-stage glaucoma, and retinal or choroidal detachment. CONCLUSIONS:: The clinical outcomes of Boston keratoprosthesis type I implantation in MMP are guarded and, as judged from the literature, less favorable than those with the Boston keratoprosthesis type II for the same disease.
Cornea 03/2013; · 1.73 Impact Factor
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ABSTRACT: PURPOSE:: To explore the feasibility and compare the outcomes of three wide-angle fundus cameras for imaging the peripheral retina through the Type 1 Boston keratoprosthesis. METHODS:: The noncontact Optos and the contact RetCam and Panoret wide-angle imaging systems were used to image the retina of eyes implanted with a keratoprosthesis. The failure-to-image rate, ease of acquisition, and quality of the images were noted, and the field of view was compared. Limitations and complications were recorded. Optos was then performed on patients referred for ultrasound B-scan evaluation, and the imaging findings were correlated. RESULTS:: Retinal images with all three cameras were obtained on four eyes. Optos could be performed on all four eyes, RetCam on three, and Panoret on two. The field of view was comparable between the three different cameras. The best quality images were obtained with Optos. The external illumination of the Panoret made it impossible to image the only darkly pigmented individual in the series. Both contact devices failed to image another patient who was too agitated. Two patients had some ocular irritation from the coupling agent that resolved with replacement of the contact lens. Optos images were obtained on an additional six eyes, and findings correlated well with those on B-scan. Optos was superior to B-scan in an eye with silicone oil filling. CONCLUSION:: Wide-angle fundus imaging through the keratoprosthesis is possible, and all three cameras performed similarly. The good quality of pictures obtained with the noncontact Optos, as well as its ease of use, comfort, and safety make it a preferred choice. Optos complements B-scan in the examination of the peripheral retina through the keratoprosthesis, and it may even be superior in certain settings.
Retina (Philadelphia, Pa.) 02/2013; · 2.93 Impact Factor
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ABSTRACT: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) is a rare but severe and sometimes fatal condition associated with exposure to medications; sulfamethoxazole is among the most common causes. We sought to address the safety of acetazolamide, a chemically related compound, in patients with prior SJS/TEN and glaucoma. A retrospective case series is described of patients at the Massachusetts Eye and Ear Infirmary who underwent keratoprosthesis surgery for corneal blindness from SJS/TEN, and later required oral acetazolamide for elevated intraocular pressure.
Over the last 10 years, 17 patients with SJS/TEN received a Boston keratoprosthesis. Of these, 11 developed elevated intraocular pressure that required administration of oral acetazolamide. One of 11 developed a mild allergic reaction, but no patient experienced a recurrence of SJS/TEN or any severe adverse reaction.
Although an increase in the rate of recurrent SJS/TEN due to oral acetazolamide would not necessarily be apparent after treating only 11 patients, in our series, acetazolamide administration was well tolerated without serious sequela.
BMC Research Notes 04/2012; 5:205.
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ABSTRACT: The purpose of this study was to evaluate the incidence of glaucoma in eyes with severe chemical burn, before and after keratoprosthesis.
A retrospective chart review of 28 eyes of 23 patients with severe ocular chemical burns who had undergone Boston Keratoprosthesis (BKPro) surgery at the Massachusetts Eye and Ear Infirmary, between 1990 and 2010. The incidence and severity of the outcome of glaucoma, preoperatively and postoperatively, were reviewed. Related issues, such as type of chemical burn; visual acuity (VA); device retention rate; number and nature of previous, concomitant, and subsequent procedures; and incidence of other postoperative complications, were reviewed for a median follow-up time of 57 months.
The number of eyes with a preoperative history or signs of glaucoma was 21, 9 of which had glaucoma progression after BKPro implantation. In addition, 2 more eyes developed glaucoma postoperatively. Preoperative vision was counting fingers or worse in all eyes. Best-corrected postoperative VA ranged from no light perception to 20/20. Seventeen eyes (61%) achieved 20/60 or better VA at some point during their follow-up, but only 9 (32%) maintained 20/60 at the last follow-up. Of the 28 eyes, 6 had the BKPro replaced once and 1 had it replaced twice. Superimposed, 8 of the most severely burned patients developed retinal detachment postoperatively.
Glaucoma is very common in eyes with severe chemical burns. A keratoprosthesis can rehabilitate vision, but postoperative glaucoma can be difficult to manage.
Cornea 12/2011; 30(12):1322-7. · 1.73 Impact Factor
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ABSTRACT: To report the long-term outcomes of Boston keratoprosthesis type II implantation in the management of severe ocular surface disease and corneal blindness through a retrospective interventional case series.
This retrospective review included medical records of patients who underwent Boston keratoprosthesis type II implantation at the Massachusetts Eye and Ear Infirmary from January 1, 2000 through December 31, 2009. The main outcome measures analyzed were visual acuity, keratoprosthesis retention, and postoperative complications.
A total of 29 eyes of 26 patients received a Boston keratoprosthesis type II during the study period. Patients undergoing operation had corneal blindness because of mucous membrane pemphigoid (51.7%), Stevens-Johnson syndrome/toxic epidermal necrolysis (41.4%), or other ocular surface disease (6.9%). Visual acuity after surgery improved to 20/200 or better in 23 eyes (79.3%) and to 20/30 or better in 10 eyes (34.5%). In patients with at least 1 year of follow-up (n = 21), visual acuity of 20/200 or better was maintained in 12 eyes (57.1%). Of 13 eyes followed-up for more than 5 years, 6 eyes (46.2%) had visual acuity of 20/200 or better at the last follow-up examination. Eyes that did not improve to 20/200 or lost vision during the follow-up had end-stage glaucoma, previous retinal detachment, or age-related macular degeneration. Of the total of 29 eyes, 17 devices (58.6%) were retained without extrusion or replacement during a total follow-up time of 107.9 person-years.
The Boston keratoprosthesis type II is a viable option for corneal blindness from severe autoimmune ocular surface diseases.
Cornea 09/2011; 30(12):1298-303. · 1.73 Impact Factor
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Irmgard Behlau,
Koushik Mukherjee,
Amit Todani,
Ann S Tisdale,
Fabiano Cade,
Liqiang Wang,
Elizabeth M Leonard,
Fouad R Zakka,
Michael S Gilmore,
Frederick A Jakobiec, Claes H Dohlman,
Alexander M Klibanov
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ABSTRACT: The biocompatibility and antibacterial properties of N,N-hexyl,methyl-polyethylenimine (HMPEI) covalently attached to the Boston Keratoprosthesis (B-KPro) materials was evaluated. By means of confocal and electron microscopies, we observed that HMPEI-derivatized materials exert an inhibitory effect on biofilm formation by Staphylococcus aureus clinical isolates, as compared to the parent poly(methyl methacrylate) (PMMA) and titanium. There was no additional corneal epithelial cell cytotoxicity of HMPEI-coated PMMA compared to that of control PMMA in tissue cultures in vitro. Likewise, no toxicity or adverse reactivity was detected with HMPEI-derivatized PMMA or titanium compared to those of the control materials after intrastromal or anterior chamber implantation in rabbits in vivo.
Biomaterials 09/2011; 32(34):8783-96. · 7.40 Impact Factor
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ABSTRACT: Integration of keratoprosthesis with the surrounding cornea is very important in preventing bacterial invasion, which may cause ocular injury. Here the authors investigated whether hydroxyapatite (HAp) coating can improve keratoprosthesis (KPro) biointegration, using polymethyl methacrylate (PMMA)--the principal component of the Boston KPro--as a model polymer.
HAp coatings were induced on PMMA discs after treatment with concentrated NaOH and coating with poly-dopamine (PDA) or polydopamine and then with 11-mercaptoundecanoic acid (11-MUA). Coatings were characterized chemically (Fourier transform infrared spectroscopy [FTIR], energy dispersive X-ray spectroscopy [EDX]) and morphologically (SEM) and were used as substrates for keratocyte growth in vitro. Cylinders of coated PMMA were implanted in porcine corneas ex vivo for 2 weeks, and the force required to pull them out was measured. The inflammatory reaction to coated discs was assessed in the rabbit cornea in vivo.
FTIR of the coatings showed absorption bands characteristic of phosphate groups, and EDX showed that the Ca/P ratios were close to those of HAp. By SEM, each method resulted in morphologically distinct HAp films; the 11-MUA group had the most uniform coating. The hydroxyapatite coatings caused comparable enhancement of keratocyte proliferation compared with unmodified PMMA surfaces. HAp coating significantly increased the force and work required to pull PMMA cylinders out of porcine corneas ex vivo. HAp coating of implants reduced the inflammatory response around the PMMA implants in vivo. Conclusions: These results are encouraging for the potential of HAp-coated surfaces for use in keratoprostheses.
Investigative ophthalmology & visual science 08/2011; 52(10):7392-9. · 3.43 Impact Factor
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ABSTRACT: To compare the rate of retroprosthetic membrane (RPM) formation in Boston Keratoprosthesis (BKPro) with polymethyl methacrylate (PMMA) versus titanium backplates.
Retrospective comparative chart review.
Multicenter study population: a total of 78 eyes with keratoprosthesis implants with either PMMA or titanium backplates were included in the study. To be included in the study, all subjects had to have completed a minimum of 6-month follow-up period. Incidence of RPM development at 6-month postoperative period was noted across the study population. PMMA and titanium backplates were then compared by their rate of association with subsequent RPM.
Twenty-three out of 55 eyes (41.8%) with PMMA backplates and three out of 23 eyes (13.0%) with titanium backplates had developed an RPM at 6 months after implantation. The titanium backplates were associated with significantly less RPM formation than PMMA backplates (p = 0.014, Chi-square test).
Titanium seems to be associated with less RPM formation than PMMA when used as a material for the BKPro back plate.
Albrecht von Graæes Archiv für Ophthalmologie 04/2011; 249(10):1515-8. · 2.17 Impact Factor
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ABSTRACT: To evaluate retroprosthetic membranes that can occur in 25% to 65% of patients with the Boston type 1 keratoprosthesis (KPro).
Two patients with Peter anomaly and 2 with neurotrophic scarred corneas underwent revisions of their type 1 KPros because of visually compromising retroprosthetic membranes. The excised membranes were studied by light microscopy with hematoxylin-eosin, periodic acid-Schiff, and toluidine blue stains. Immunohistochemical and transmission electron microscopic examination were also used.
Light microscopic examination revealed that the retro-KPro fibrous membranes originated from the host's corneal stroma. These mildly to moderately vascularized membranes grew through gaps in the Descemet membrane to reach behind the KPro back plate and adhere to the anterior iris surface, which had undergone partial lysis. In 2 cases, the fibrous membranes merged at the pupil with matrical portions of metaplastic lens epithelium, forming a bilayered structure that crossed the optical axis. Retro-KPro membranes stained positively for α-smooth muscle actin but negatively for pancytokeratin. Electron microscopy confirmed the presence of actin filaments within myofibroblasts and small surviving clusters of metaplastic lens epithelial cells.
Stromal downgrowth, rather than epithelial downgrowth, was the major element of the retro-KPro membranes in this series. Metaplastic lens epithelium also contributed to opacification of the visual axis. Florid membranous inflammation was not a prominent finding and thus probably not a requisite stimulus for membrane development. Further advances in prosthetic design and newer antifibroproliferative agents may reduce membrane formation.
Archives of ophthalmology 03/2011; 129(3):310-6. · 3.86 Impact Factor
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Cornea 01/2011; 30(6):613-4. · 1.73 Impact Factor
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ABSTRACT: To determine the biocompatibility of a new wireless intraocular pressure (IOP) transducer (WIT) in rabbit eyes and to correlate its measurements with other pressure-measuring devices.
The WIT is a ring-shaped intraocular device that allows wireless IOP measurements through radiofrequency. It was implanted into six eyes of New Zealand White rabbits after extracapsular lens extraction. A sham rabbit eye with no transducer implanted was used as a control. The animals were observed and examined by microscopy at various intervals up to 25 months after surgery. IOP was measured at various intervals by pneumotonometry, tonometry, WIT, and manometry. The data from the various devices were compared and analyzed for reproducibility. Two eyes were enucleated at 5.5 and 20 months after implantation and analyzed by histology.
The WIT appears to be well tolerated in the rabbit eye, with no evidence of significant inflammation or scar formation by microscopic in vivo examination. Histology did not reveal intraocular inflammation or membrane formation. Repeated IOP measurements with pneumotonometry, tonometry, and the WIT resulted in SDs of 2.70 mm Hg, 3.35 mm Hg, and 0.81 mm Hg, respectively. The concordance between the WIT and direct manometry measurements was high. A downward drift in IOP measured by the WIT was noted in three rabbits, necessitating recalibration.
The WIT is well tolerated by the rabbit eye. Its measurements are reproducible and in close concordance with manometry. A downward IOP drift warrants further investigation.
Investigative ophthalmology & visual science 01/2011; 52(13):9573-80. · 3.43 Impact Factor
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ABSTRACT: To describe the clinical features and course of 2 patients with autoimmune diseases and their experience with the Boston keratoprosthesis. To draw on general medical literature to try to better understand recurrent complications.
Retrospective review of 2 patients treated with Boston keratoprostheses. The clinical histories, examinations, and other diagnostics were reviewed. A literature review was performed.
The first patient presented with end-stage ocular disease secondary to toxic epidermal necrolysis (TENS). The second patient presented with end-stage ocular disease secondary to mucous membrane pemphigoid (MMP). Both patients underwent treatment with the Boston keratoprosthesis. Both patients suffered numerous corneal melts requiring multiple repeat implantations.
Patients with corneal blindness secondary to autoimmune disease often fare poorly with available surgical treatments. Study of existing literature on prosthetic device complications in autoimmune diseases may help uncover common mechanisms of tissue destruction to establish perioperative immunomodulatory regimens targeted to specific underlying diseases.
Ocular immunology and inflammation 08/2010; 18(4):275-80. · 0.72 Impact Factor
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American journal of ophthalmology 04/2010; 149(4):537-9. · 3.83 Impact Factor
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ABSTRACT: To conduct a cost-utility analysis and determine the cost-effectiveness of the Boston Keratoprosthesis (Boston Kpro).
Retrospective cohort study.
setting: The Massachusetts Eye and Ear Infirmary corneal service. patients: Inclusion required a minimum 2-year follow-up. Patients with autoimmune diseases and chemical burns were excluded. Eighty-two patients were included with various indications for surgery. intervention: The keratoprosthesis is a collar button-shaped polymethylmethacrylate (PMMA) device consisting of 2 curved plates sandwiched around a corneal donor (allo)graft. The device is assembled intraoperatively and sutured to a patient's eye after removing the diseased cornea.
Average cost-effectiveness of the keratoprosthesis was determined by cost-utility analysis, using expected-value calculations and time-tradeoff utilities. The comparative effectiveness, or gain in quality-adjusted life years (QALYs), was also sought. Cost-effectiveness was compared to recently published data on penetrating keratoplasty (PK).
A total discounted incremental QALY gain for the Boston Kpro of 0.763 correlated with a conferred QALY gain of 20.3% for the average patient. The average cost-effectiveness of the keratoprosthesis was $16 140 per QALY.
Comparable to corneal transplantation, with a cost-effectiveness between $12 000 and $16 000 per QALY, the keratoprosthesis can be considered highly cost-effective.
American journal of ophthalmology 11/2009; 149(2):221-228.e2. · 3.83 Impact Factor
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ABSTRACT: To evaluate the optical characteristics of the Boston Keratoprosthesis (KPro), identify glare sources, evaluate possible glare control, and examine the benefit of implantation when the fellow eye has normal vision.
Computed and optical-bench-measured point spread function (PSF) and glare sources were compared. A translucent plastic cornea was used to determine the impact of glare caused by scatter in the cornea and its control with a dark-iris tinted contact lens. The effect of glare in implanted eyes was measured with a brightness acuity test (BAT), with and without the dark-iris contact lens. Computed and measured visual fields were compared. Stereopsis was measured in patients with an intact fellow eye.
Computed and measured modulation transfer functions for the KPro were found to be very close to the diffraction limit. Both the model-eye measurements and patients' BAT glare responses identified that the hazy corneal graft surrounding the KPro is the main source of glare and can be controlled with a dark-iris contact lens. The lid effectively blocks the light that would be scattered in the hazy cornea of patients in whom the type II KPro was implanted. An intact fellow eye remains the dominant eye, with better acuity, and the KPro eye supports only minimal stereo ability and does not expand the binocular visual field.
Glare can be reduced significantly with the use of a contact lens with a dark iris. Implanting the KPro in a patient whose fellow eye has normal or near normal vision does not seem to improve visual function.
Investigative ophthalmology & visual science 10/2009; 51(2):857-63. · 3.43 Impact Factor
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ABSTRACT: To evaluate the efficacy and safety of diode laser transscleral cyclophotocoagulation (DLTSC) to control intraocular pressure (IOP) in keratoprosthesis patients with uncontrolled glaucoma.
Between 1993 and 2007, 18 eyes of 18 patients underwent DLTSC, either before (n=3), during (n=1), or after (n=14) keratoprosthesis surgery. Keratoprosthesis type I was used in 72%. All but one of these patients received an Ahmed Glaucoma Valve, either with or after the keratoprosthesis placement. Best-corrected visual acuity, IOP (assessed by digital palpation), number of medications, and complications were recorded preoperatively, at day 7, at 1, 3, and 6 months then every 6 months postoperatively.
Mean follow-up was 26.6+/-19.6 months (mean+/-SD) and mean age was 50.1+/-15.6 years. Glaucoma was identified in 11 eyes before keratoprosthesis surgery and in 7 eyes after. Mean postoperative IOP was significantly reduced at 6, 12, 24, 36, and 48 months after DLTSC. DLTSC was repeated in 6 eyes. At final visit, mean best-corrected visual acuity was not decreased and there were no statistically significant differences in the number of glaucoma medications. Two patients had complications after DLTSC: a conjunctival dehiscence and a fungal endophthalmitis.
DLTSC has beneficial long-term effects in the control of IOP and can be considered in the management of keratoprosthesis patients with refractory glaucoma.
Journal of glaucoma 03/2009; 18(4):321-4. · 1.74 Impact Factor
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ABSTRACT: To formulate and characterize a drug-eluting contact lens designed to provide extended, controlled release of a drug.
Prototype contact lenses were created by coating PLGA (poly[lactic-co-glycolic acid]) films containing test compounds with pHEMA (poly[hydroxyethyl methacrylate]) by ultraviolet light polymerization. The films, containing encapsulated fluorescein or ciprofloxacin, were characterized by scanning electron microscopy. Release studies were conducted in phosphate-buffered saline at 37 degrees C with continuous shaking. Ciprofloxacin eluted from the contact lens was studied in an antimicrobial assay to verify antimicrobial effectiveness.
After a brief and minimal initial burst, the prototype contact lenses demonstrated controlled release of the molecules studied, with zero-order release kinetics under infinite sink conditions for over 4 weeks. The rate of drug release was controlled by changing either the ratio of drug to PLGA or the molecular mass of the PLGA used. Both the PLGA and the pHEMA affected release kinetics. Ciprofloxacin released from the contact lenses inhibited ciprofloxacin-sensitive Staphylococcus aureus at all time-points tested.
A prototype contact lens for sustained drug release consisting of a thin drug-PLGA film coated with pHEMA could be used as a platform for ocular drug delivery with widespread therapeutic applications.
Investigative ophthalmology & visual science 02/2009; 50(7):3346-52. · 3.43 Impact Factor
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International Ophthalmology Clinics 02/2009; 49(1):1-9.
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ABSTRACT: In eyes with corneal disease and opacity so severe that standard corneal transplantation carries a poor prognosis, a keratoprosthesis (KPro) may still be successful in providing functional visual acuity. The purpose of this study was to determine the outcome of Boston KPro implantation in the rehabilitation of severe ocular trauma.
This is a retrospective study of 30 eyes (30 patients) with severe ocular trauma that underwent Boston KPro type I implantation at the Massachusetts Eye and Ear Infirmary. Of these 30 eyes, 6 had mechanical trauma, 21 had chemical burns, and 3 had thermal burns. The measures used in this review are 5-fold: (i) anatomic success; (ii) number of postoperative repair procedures performed; (iii) preoperative and postoperative visual acuity; (iv) number of eyes with concomitant preoperative retinal or optic nerve damage prior to KPro surgery; and (v) incidence of postoperative complications.
Preoperative visual acuity ranged from counting fingers to light perception (median: hand motion). Best-corrected postoperative visual acuity ranged from 20/20 to no light perception (median: 20/80). Anatomic success was achieved in 5 out of 5 mechanically traumatized eyes, 14 out of 17 eyes with chemical burns, and 3 out of 3 eyes with thermal burns. Repair procedures were done in 8 of the 17 chemically burned eyes. The number of eyes with concomitant preoperative ocular disease was 2 out of 6 in the mechanical trauma group, 10 out of 21 in the chemical burn group, and 1 out of 3 in the thermal burn group. The incidence of postoperative complications was greater in the chemical burn group than in either the mechanical trauma or the thermal burn group.
The Boston KPro can provide considerable visual improvement and a long-term anatomic retention rate in severely traumatized eyes. The overwhelming danger in severe chemical burns is glaucoma progression despite a functioning tube implant and normal intraocular pressure.
Canadian Journal of Ophthalmology 05/2008; 43(2):165-9. · 1.47 Impact Factor
