Comparison of Contact Lens and Intraocular Lens Correction of Monocular Aphakia During Infancy

Abstract

The Infant Aphakia Treatment Study Group IMPORTANCE The efficacy and safety of primary intraocular lens (IOL) implantation during early infancy is unknown.OBJECTIVE To compare the visual outcomes of patients optically corrected with contact lenses vs IOLs following unilateral cataract surgery during early infancy. DESIGN, SETTING, AND PARTICIPANTSThe Infant Aphakia Treatment Study is a randomized clinical trial with 5 years of follow-up that involved 114 infants with unilateral congenital cataracts at 12 sites. A traveling examiner assessed visual acuity at age 4.5 years.INTERVENTIONS Cataract surgery with or without primary IOL implantation. Contact lenses were used to correct aphakia in patients who did not receive IOLs. Treatment was determined through random assignment.MAIN OUTCOMES AND MEASURES HOTV optotype visual acuity at 4.5 years of age. RESULTSThe median logMAR visual acuity was not significantly different between the treated eyes in the 2 treatment groups (both, 0.90 [20/159]; P = .54). About 50% of treated eyes in both groups had visual acuity less than or equal to 20/200. Significantly more patients in the IOL group had at least 1 adverse event after cataract surgery (contact lens, 56%; IOL, 81%; P = .02). The most common adverse events in the IOL group were lens reproliferation into the visual axis, pupillary membranes, and corectopia. Glaucoma/glaucoma suspect occurred in 35% of treated eyes in the contact lens group vs 28% of eyes in the IOL group (P = .55). Since the initial cataract surgery, significantly more patients in the IOL group have had at least 1 additional intraocular surgery (contact lens, 21%; IOL, 72%; P < .001). CONCLUSIONS AND RELEVANCEThere was no significant difference between the median visual acuity of operated eyes in children who underwent primary IOL implantation and those left aphakic. However, there were significantly more adverse events and additional intraoperative procedures in the IOL group. When operating on an infant younger than 7 months of age with a unilateral cataract, we recommend leaving the eye aphakic and focusing the eye with a contact lens. Primary IOL implantation should be reserved for those infants where, in the opinion of the surgeon, the cost and handling of a contact lens would be so burdensome as to result in significant periods of uncorrected aphakia. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00212134

Motor skills of children with unilateral visual impairment in the Infant Aphakia Treatment Study

“…During the 4.5 year visit (mean, 4.5 years; range, 4.5–4.9 years), monocular recognition visual acuity and monocular fixation stability were evaluated, followed by testing of motor skills, and then assessment of stereopsis 11 . Motor skills were assessed while the child had optimal visual correction and was not patched.…”

Postoperative Glaucoma Following Infantile Cataract Surgery

“…9,10 Although no statistically significant difference was found in the incidence of glaucoma between the aphakic and pseudophakic arms of the study at 12 months, results of a longer follow-up are expected to elucidate the aforementioned questions. These results may take several years, because postoperative glaucoma can have a delayed onset.…”

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

“…1–12 The Infant Aphakia Treatment Study (IATS) - a multi-center, randomized, controlled clinical trial sponsored by the National Eye Institute – compares outcomes of surgery for unilateral cataract with primary intraocular lens (IOL) implantation to surgery without IOL implantation in infants between 1 and 6 months of age. 13–17 …”