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Clinical Trials
July 2010

A Randomized Clinical Trial Comparing Contact Lens With Intraocular Lens Correction of Monocular Aphakia During InfancyGrating Acuity and Adverse Events at Age 1 Year

The Infant Aphakia Treatment Study Group
Arch Ophthalmol. 2010;128(7):810-818. doi:10.1001/archophthalmol.2010.101
Abstract

Objective  To compare the visual outcomes and adverse events of contact lens with primary intraocular lens (IOL) correction of monocular aphakia during infancy.

Methods  In a randomized, multicenter (12 sites) clinical trial, 114 infants with a unilateral congenital cataract were assigned to undergo cataract surgery between 1 to 6 months of age either with or without primary IOL implantation. Contact lenses were used to correct aphakia in patients who did not receive IOLs. Grating visual acuity was tested at 1 year of age by a masked traveling examiner.

Main Outcome Measure  Grating visual acuity at 1 year of age.

Results  The median logMAR visual acuity was not significantly different between the treated eyes in the 2 groups (contact lens group, 0.80; IOL group, 0.97; P = .19). More patients in the IOL group underwent 1 or more additional intraocular operations than patients in the contact lens group (63% vs 12%; P < .001). Most of these additional operations were performed to clear lens reproliferation and pupillary membranes from the visual axis.

Conclusions  There was no statistically significant difference in grating visual acuity at age 1 year between the IOL and contact lens groups; however, additional intraocular operations were performed more frequently in the IOL group.

Application to Clinical Practice  Until longer-term follow-up data are available, caution should be exercised when performing IOL implantation in children aged 6 months or younger given the higher incidence of adverse events and the absence of an improved short-term visual outcome compared with contact lens use.

Trial Registration  clinicaltrials.gov Identifier: NCT00212134Published online May 10, 2010 (doi:10.1001/archophthalmol.2010.101).

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