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Clinical Trials |

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

Arch Ophthalmol. 2010;128(7):810-818. doi:10.1001/archophthalmol.2010.101.
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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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Figure 1.

Flow diagram illustrating the progress of patients throughout the Infant Aphakia Treatment Study. For all randomized patients, the primary outcome, grating acuity at 1 year of age, was measured by a traveling examiner. No patients assigned to the intraocular lens (IOL) group had the IOL removed; no patients assigned to the contact lens group had an IOL implanted.

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Figure 2.

Histograms of logMAR visual acuity of treated eyes at 1 year of age. Visual acuity was assessed using Teller Acuity Cards. The numbers below the bars indicate the number of patients in the acuity category. Median visual acuity was 0.80 (interquartile range, 0.66-0.97) and 0.97 (interquartile range, 08.0-1.10) in the contact lens and the intraocular lens group, respectively (P = .19).

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Figure 3.

Histograms showing the percentage of parents reporting that they patched the untreated eye of their child at least 75% of the prescribed time at different time points after cataract surgery.

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