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Randomized Controlled Trial
. 2010 Jul;128(7):810-8.
doi: 10.1001/archophthalmol.2010.101. Epub 2010 May 10.

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

Infant Aphakia Treatment Study Group  1 ; Scott R Lambert, Edward G Buckley, Carolyn Drews-Botsch, Lindreth DuBois, E Eugenie Hartmann, Michael J Lynn, David A Plager, M Edward Wilson
Collaborators, Affiliations
Randomized Controlled Trial

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

Infant Aphakia Treatment Study Group et al. Arch Ophthalmol. 2010 Jul.

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 NCT00212134.

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Figures

Figure 1
Figure 1
Flow diagram illustrating the progress of patients throughout the IATS.
Figure 2
Figure 2
Histograms of logMAR visual acuity of treated eyes at 1 year of age for the treatment groups. Visual acuity was assessed using Teller acuity cards. The numbers above the bars indicate the number of patients in the acuity category (LV = Low Vision Card; LP = Light Perception).
Figure 3
Figure 3
Histograms of logMAR visual acuity of untreated eyes at 1 year of age for the treatment groups. Visual acuity was assessed using Teller acuity cards. The numbers above the bars indicate the number of patients in the acuity category (LV = Low Vision Card; LP = Light Perception).
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References

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