Glaucoma-Related Adverse Events in the First 5 Years After Unilateral Cataract Removal in the Infant Aphakia Treatment Study

Abstract

for the Infant Aphakia Treatment Study Group IMPORTANCE Glaucoma-related adverse events constitute major sight-threatening complications of cataract removal in infancy, yet their relationship to aphakia vs primary intraocular lens (IOL) implantation remains unsettled.OBJECTIVE To identify and characterize cases of glaucoma and glaucoma-related adverse events (glaucoma + glaucoma suspect) among children in the Infant Aphakia Treatment Study by the age of 5 years. DESIGN, SETTING, AND PARTICIPANTSA multicenter randomized clinical trial of 114 infants with unilateral congenital cataract in referral centers who were between ages 1 and 6 months at surgery. Mean follow-up was 4.8 years. This secondary analysis was conducted from December 23, 2004, to November 13, 2013.INTERVENTIONS Participants were randomized at cataract surgery to either primary IOL or no IOL implantation (contact lens). Standardized definitions of glaucoma and glaucoma suspect were created for the Infant Aphakia Treatment Study and applied for surveillance and diagnosis.MAIN OUTCOMES AND MEASURES Development of glaucoma and glaucoma + glaucoma suspect in operated on eyes for children up to age 5 years, plus intraocular pressure, visual acuity, and axial length at age 5 years.RESULTS Product limit estimates of the risk for glaucoma and glaucoma + glaucoma suspect at 4.8 years after surgery were 17% (95% CI, 11%-25%) and 31% (95% CI, 24%-41%), respectively. The contact lens and IOL groups were not significantly different for either outcome: glaucoma (hazard ratio [HR], 0.8; 95% CI, 0.3-2.0; P = .62) and glaucoma + glaucoma suspect (HR, 1.3; 95% CI, 0.6-2.5; P = .58). Younger (vs older) age at surgery conferred an increased risk for glaucoma (26% vs 9%, respectively) at 4.8 years after surgery (HR, 3.2; 95% CI, 1.2-8.3), and smaller (vs larger) corneal diameter showed an increased risk for glaucoma + glaucoma suspect (HR, 2.5; 95% CI, 1.3-5.0). Age and corneal diameter were significantly positively correlated. Glaucoma was predominantly open angle (19 of 20 cases, 95%), most eyes received medication (19 of 20, 95%), and 8 of 20 eyes (40%) underwent surgery.CONCLUSIONS AND RELEVANCE These results suggest that glaucoma-related adverse events are common and increase between ages 1 and 5 years in infants after unilateral cataract removal at 1 to 6 months of age; primary IOL placement does not mitigate their risk but surgery at a younger age increases the risk. Longer follow-up of these children may further characterize risk factors, long-term outcomes, potential differences between eyes having primary IOL vs aphakia, and optimal timing of unilateral congenital cataract removal. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00212134

Comparison of the rate of refractive growth in aphakic eyes versus pseudophakic eyes in the Infant Aphakia Treatment Study

“…Glaucoma and glaucoma suspect were diagnosed as reported previously. 12,13 At age 5 years, a cycloplegic refraction was performed. An overrefraction was performed for children wearing a contact lens.…”

Quality of life and functional vision in children treated for cataract—a cross-sectional study

“…If glaucoma develops, additional treatment in the form of eye drops (95%) 2 or glaucoma surgery (up to 40% at 5 years of follow-up) 2 is required, carrying an additional burden of anxiety for the child and the family. Yet little is known about the impact of cataract and its management on children and their families.…”

Association of Contact Lens Adherence With Visual Outcome in the Infant Aphakia Treatment Study

“…Second, there are likely many other factors that influenced visual outcomes in addition to contact lens adherence including patching adherence, age at surgery, socioeconomic factors and adverse events. ,12,13 Lastly, our sample size may have been too small to identify a significant relationship between contact lens adherence and visual outcomes.…”