ABSTRACT
IMPORTANCE: Children born prematurely who develop retinopathy of prematurity (ROP) often develop myopia, and those who require laser treatment may develop very high myopia, which has considerable clinical consequences. OBJECTIVE: To report refractive outcomes in preterm infants who developed ROP in zone I or zone II posterior as stage 3+ ROP or aggressive posterior ROP (APROP). DESIGN, SETTING, AND PARTICIPANTS: All infants received intravitreal bevacizumab or laser therapy in a prospective, stratified, randomized, controlled, masked, multicenter clinical trial, Bevacizumab Eliminates the Angiogenic Threat for ROP (BEAT-ROP). Children who received intravitreal bevacizumab or laser in the BEAT-ROP clinical trial, with treatment randomized by infant, underwent cycloplegic retinoscopic refraction at a mean age of 2½ years. Fifteen centers with both pediatric and vitreoretinal ophthalmologists participating in level 3 neonatal intensive care units in academic centers with institutional review board approval were included in the trial. Of the originally enrolled 150 infants (300 eyes) in the BEAT-ROP clinical trial, 13 infants (26 eyes) died (6 received intravitreal bevacizumab; 7 received laser) and 19 eyes had intraocular surgery (6 infants bilaterally). Thus, 45 eyes (19 infants bilaterally) were excluded, leaving 131 infants (255 eyes, including 21 eyes that received a successful second treatment for recurrence). INTERVENTIONS: Follow-up of the BEAT-ROP cohort. MAIN OUTCOMES AND MEASURES: Spherical equivalent refractive outcomes and their distribution by ROP zone and treatment. RESULTS: Refractions were available for 109 of 131 eligible infants (83.2%) and 211 of 255 eyes (82.7%). Mean (SD) spherical equivalent refractions were as follows: zone I, -1.51 (3.42) diopters (D) in 52 eyes that received intravitreal bevacizumab and -8.44 (7.57) D in 35 eyes that received laser treatment (P < .001); and zone II posterior, -0.58 (2.53) D in 58 eyes that received intravitreal bevacizumab and -5.83 (5.87) D in 66 eyes that received laser treatment (P < .001). Very high myopia (≥-8.00 D) occurred in zone I in 2 of 52 (3.8%) eyes that received intravitreal bevacizumab and in 18 of 35 (51.4%) eyes that received laser treatment (P < .001). Very high myopia occurred in zone II posterior in 1 of 58 (1.7%) eyes that received intravitreal bevacizumab and in 24 of 66 (36.4%) eyes that received laser treatment (P < .001). CONCLUSIONS AND RELEVANCE: More very high myopia was found in eyes that received laser treatment than in eyes that received intravitreal bevacizumab. This difference is possibly related to anterior segment development that is present with intravitreal bevacizumab but minimal or absent following laser treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00622726.
Subject(s)
Angiogenesis Inhibitors/adverse effects , Antibodies, Monoclonal, Humanized/adverse effects , Laser Coagulation/adverse effects , Myopia, Degenerative/etiology , Retinopathy of Prematurity/therapy , Angiogenesis Inhibitors/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Bevacizumab , Child, Preschool , Double-Blind Method , Follow-Up Studies , Gestational Age , Humans , Infant, Extremely Low Birth Weight , Infant, Premature , Intravitreal Injections , Laser Coagulation/methods , Myopia, Degenerative/diagnosis , Prospective Studies , Refraction, Ocular/physiology , Retinopathy of Prematurity/drug therapy , Retinopathy of Prematurity/surgery , Retinoscopy , Vascular Endothelial Growth Factor A/antagonists & inhibitors , Visual Acuity/physiologyABSTRACT
BACKGROUND: Monofixation syndrome is characterized by small-angle strabismus with vergence fusional amplitudes and "peripheral fusion." Although it is thought to be a relatively stable condition, some patients with this syndrome deteriorate, resulting in an increasing heterotropia, sometimes associated with diplopia. Deteriorated monofixation syndrome is well known among clinicians; however, there are no studies describing the course and outcomes for these patients. PURPOSE: To assess the clinical characteristics, course, and response to therapy of patients with deteriorated monofixation syndrome. METHODS: We identified all patients from our database that had an ocular deviation of < or =8 Delta on simultaneous prism cover testing, peripheral fusion, and between 3000 and 67 seconds of stereoacuity (monofixators) who subsequently had an increase in their deviation to >8 Delta, loss of fusion, or diplopia. From this group we assessed patient clinical characteristics, course, and response to therapy. RESULTS: We identified 29 patients with deteriorated monofixation syndrome who subsequently underwent treatment. Treatment consisted of surgery in 28 patients and minus lens therapy in one patient. Of the study group, 28 (97%) of the patients had a history of esotropia and 20 patients (69%) had a history of amblyopia. Nine patients noted diplopia at the time of deterioration, which persisted in four patients after treatment. In all, 14 patients (48%) met the criteria for monofixation again after therapy, while 20 patients (69%) had successful motor alignment (< or =8 Delta). There was a trend toward poorer outcomes in the diplopic group when compared with the patients who did not have diplopia, although this was not statistically significant (P = 0.26 for regaining monofixation syndrome). Follow-up ranged from 1 month to 21 years. CONCLUSION: Though monofixation is considered a stable condition, some patients will deteriorate over time as demonstrated by an increase in the ocular deviation and loss of fusion. In this study 31% of our patients noted the onset of diplopia. Following treatment, 48% of the patients regained monofixation. Patients with diplopia following deterioration of their alignment may be less likely to regain good alignment or monofixation after treatment.
