To compare grating (resolution) visual acuity at 6 years of age in eyes that received early treatment (ET) for high-risk prethreshold retinopathy of prematurity (ROP) with that in eyes that underwent conventional management (CM).
In a randomized clinical trial, infants with bilateral, high-risk prethreshold ROP (n = 317) had one eye undergo ET and the other eye undergo CM, with treatment only if ROP progressed to threshold severity. For asymmetric cases (n = 84), the high-risk prethreshold eye was randomized to ET or CM.
Grating visual acuity measured at 6 years of age by masked testers using Teller acuity cards.
Monocular grating acuity results were obtained from 317 of 370 surviving children (85.6%). Analysis of grating acuity results for all study participants with high-risk prethreshold ROP showed no statistically significant overall benefit of ET (18.1% vs 22.8% unfavorable outcomes; P = .08). When the 6-year grating acuity results were analyzed according to a clinical algorithm (high-risk types 1 and 2 prethreshold ROP), a benefit was seen in type 1 eyes (16.4% vs 25.2%; P = .004) undergoing ET, but not in type 2 eyes (21.3% vs 15.9%; P = .29).
Early treatment of eyes with type 1 ROP improves grating acuity outcomes, but ET for eyes with type 2 ROP does not. APPLICATION TO CLINICAL MEDICINE: Type 1 eyes should be treated early; however, based on acuity results at 6 years of age, type 2 eyes should be cautiously monitored for progression to type 1 ROP. Trial Registration clinicaltrials.gov Identifier: NCT00027222.
"Retinopathy of prematurity (ROP) is a vasoproliferative disease of the retina, that is, one of the most common causes of infant and childhood blindness . Fortunately, the visual impairment related to ROP is largely preventable with timely treatment  after its diagnosis by ophthalmoscopic examination  . However, it has recently been reported that disagreement may arise between ophthalmologists regarding the existence of plus disease , indicating subjectivity in diagnosis based on indirect ophthalmoscopic examination. "
[Show abstract][Hide abstract] ABSTRACT: Purpose. To examine the macular findings obtained with spectral domain optical coherence tomography (SD OCT) in infants with retinopathy of prematurity (ROP). Materials and Methods. The macular SD OCT images of 190 premature infants were analyzed. Data regarding central foveal thickness (CFT), cystoid macular edema (CME), and cyst grading were compared. The relationships of CFT with gestational age and birth weight were investigated. Results. The results were obtained from 358 eyes of 179 infants (81 females and 98 males) of a mean gestational age of weeks and a mean birth weight of g. ROP was diagnosed in 126 eyes and CME in 139 eyes. A significantly greater percentage of eyes with ROP were found to have CME (54%) compared to eyes without ROP (31%; ). The incidence of CME was 46.3% for stage 1 ROP, 57.1% for stage 2, and 87.5% for stage 3. There was a weakly inverse correlation between CFT, gestational age, and birth weight (, ; , , resp., Spearman correlation test). Conclusions. High-quality SD OCT images can be obtained from premature infants using the iVue system. Severity and frequency of CME in premature infants increase as stage of ROP increases
Journal of Ophthalmology 12/2014; 2014. DOI:10.1155/2014/468653 · 1.43 Impact Factor
"The 2-year data collected in the ETROP study showed that unfavourable structural outcomes (defined as retinal folds or detachment) decreased in eyes that received early ablative therapy . Visual acuity improved at 6 years of age only in newborns with Type 1 high-risk prethreshold eyes  (those with plus disease in either Zone I or Zone II, or Zone I stage 3 disease) . Long-term structural and functional outcomes suggest that laser photocoagulation is superior to cryotherapy [35,36]. "
[Show abstract][Hide abstract] ABSTRACT: Despite new therapeutic approaches have improved the prognosis of newborns with retinopathy of prematurity (ROP), an unfavourable structural and functional outcome still remains high. There is high pressure to develop new drugs to prevent and treat ROP. There is increasing enthusiasm for anti-VEGF drugs, but angiogenic inhibitors selective for abnormal blood vessels would be considered as an optimal treatment.In an animal experimental model of proliferative retinopathy, we have recently demonstrated that the pharmacological blockade of beta-adrenoreceptors improves retinal neovascularization and blood retinal barrier breakdown consequent to hypoxia. The purpose of this study is to evaluate the propranolol administration in preterm newborns suffering from a precocious phase of ROP in terms of safety and efficacy in counteracting the progression of retinopathy.
Preterm newborns (gestational age at birth lower than 32 weeks) with stage 2 ROP (zone II-III without plus) will be randomized, according to their gestational age, to receive propranolol added to standard treatment (treatment adopted by the ETROP Cooperative Group) or standard treatment alone. Propranolol will be administered until retinal vascularization will be completely developed, but not more than 90 days. Forty-four participants will be recruited into the study. To evaluate the safety of propranolol administration, cardiac and respiratory parameters will be continuously monitored. Blood samplings will be performed to check renal, liver and metabolic balance. To evaluate the efficacy of propranolol, the progression of the disease, the number of laser treatments or vitrectomies, the incidence of retinal detachment or blindness, will be evaluated by serial ophthalmologic examinations. Visual function will be evaluated by means of behavioural standardized tests.
This pilot study is the first research that explores the possible therapeutic role of beta blockers in ROP. The objective of this research is highly ambitious: to find a treatment simple, inexpensive, well tolerated and with few adverse effects, able to counteract one of the major complications of the prematurity. Any favourable results of this research could open new perspectives and original scenarios about the treatment or the prevention of this and other proliferative retinopathies.
Current Controlled Trials ISRCTN18523491; ClinicalTrials.gov Identifier NCT01079715; EudraCT Number 2010-018737-21.
[Show abstract][Hide abstract] ABSTRACT: Despite current treatments, retinopathy of prematurity (ROP) remains a major cause of blindness in premature infants and the incidence is increasing with increased survival of infants born at very early gestational ages. This review summarizes the recent literature on ROP with a special focus on recent advances in treatment options as well as newly developed methods for disease screening.
Genetic studies find a genetic predisposition to ROP-linking genes in the Wnt pathway with development of severe ROP. With regard to diagnosis, a new screening method has been developed that allows prediction of ROP risk based on postnatal body weight gain alone. Formerly weight gain postnatally in combination with insulin-like growth factor levels was found to predict treatable ROP. New treatment options for severe cases of ROP have been proposed targeting vascular endothelial growth factor (VEGF). Whether anti-VEGF treatment is well tolerated in preterm infants, however, has to be further evaluated in controlled clinical trials. Finally, new reports from the early treatment ROP group suggest that early laser treatment for type 1 but not type 2 high-risk prethreshold ROP improves visual acuity outcomes at 6 years of age.
With the increasing survival of premature infants and increased incidence of ROP, it is important to screen for ROP risk and treat at-risk patients in a timely manner to preserve their visual function and reduce complications.
Current opinion in pediatrics 12/2010; 23(2):173-8. DOI:10.1097/MOP.0b013e3283423f35 · 2.53 Impact Factor
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