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Randomized Controlled Trial
. 2020 Apr 1;138(4):365-372.
doi: 10.1001/jamaophthalmol.2020.0006.

Long-term Effect of Intraocular Lens vs Contact Lens Correction on Visual Acuity After Cataract Surgery During Infancy: A Randomized Clinical Trial

Scott R Lambert  1 , George Cotsonis  2 , Lindreth DuBois  3 , Azhar Nizam Ms  2 , Stacey J Kruger  4 , E Eugenie Hartmann  5 , David R Weakley Jr  6 , Carolyn Drews-Botsch  7 ; Infant Aphakia Treatment Study Group
Affiliations
Randomized Controlled Trial

Long-term Effect of Intraocular Lens vs Contact Lens Correction on Visual Acuity After Cataract Surgery During Infancy: A Randomized Clinical Trial

Scott R Lambert et al. JAMA Ophthalmol. .

Abstract

Importance: Although intraocular lenses (IOLs) are often implanted in children, little is known whether primary IOL implantation or aphakia and contact lens correction results in better long-term visual outcomes after unilateral cataract surgery during infancy.

Objective: To compare long-term visual outcomes with contact lens vs IOL correction following unilateral cataract surgery during infancy.

Design, setting, and participants: This multicenter randomized clinical trial enrolled 114 infants with a unilateral congenital cataract who underwent cataract surgery with or without primary IOL implantation between 1 and 6 months of age. Data on long-term visual outcomes were collected when the children were age 10.5 years (July 14, 2015, to July 12, 2019) and analyzed from March 30 through August 6, 2019.

Interventions: Intraocular lens implantation at the time of cataract surgery.

Main outcomes and measures: Best-corrected visual acuity using the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) testing protocol. Analysis was performed on an intention-to-treat basis.

Results: Best-corrected visual acuity was measured at age 10.5 years for 110 of the 114 patients (96%) enrolled as infants. The participants included 58 girls (53%) and 52 boys (47%). Overall, 27 of the children (25%) had good (logMAR 0.30 [Snellen equivalent, 20/40] or better) visual acuity in the treated eye (12 [22%] in the IOL group and 15 [27%] in the aphakia group), but 50 children (44%) had a visual acuity of logMAR 1.00 (Snellen equivalent, 20/200) or worse (25 [44%] in the IOL group and 25 [44%] in the aphakia group). The median logMAR acuity in the treated eye was similar in children randomized to receive an IOL at the time of cataract extraction (0.89; interquartile range [IQR], 0.33-1.43 [Snellen equivalent, 20/159]) and those who remained aphakic (0.86; IQR, 0.30-1.46 [Snellen equivalent, 20/145]) (IQR, 0.30-1.46; P = .82). Although the overall difference in median visual acuity between the 2 groups was small, the estimate was imprecise (99% CI for the difference in medians was -0.54 to 0.47).

Conclusions and relevance: As in previous phases of the study, visual acuity outcomes were highly variable with only 27 children (25%) achieving excellent visual acuity in their treated eye and 50 children (44%) having poor vision in the treated eye. Implanting an IOL at the time of cataract extraction was neither beneficial nor detrimental to the visual outcome.

Trial registration: ClinicalTrials.gov Identifier: NCT00212134.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Cotsonis reported grants from Emory University during the conduct of the study. Dr DuBois reported grants from NIH/NEI during the conduct of the study. Dr Nizam reported grants from NIH during the conduct of the study. Dr Drews-Botsch reported grants from NIH/NEI during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram for the Infant Aphakia Treatment Study
IOL indicates intraocular lens. aIntraoperatively, stretching of ciliary processes was found; the investigator decided that an IOL could not be safely implanted. The patient remained aphakic and was treated with a contact lens.
Figure 2.
Figure 2.. LogMAR Visual Acuity (VA) of Treated Eyes at Age 10.5 Years
The number above each bar refers to the number of patients in this acuity category. A, In the aphakia group, median VA was 0.86 (Snellen equivalent, 20/145) (interquartile range, 0.30-1.46; Snellen equivalent, 20/48-20/480). One patient had hand motion acuity (defined as logMAR, 2.64); 1, light perception acuity (defined as logMAR, 2.78); and 1, no light perception (defined as logMAR, 2.93). B, In the intraocular lens (IOL) group, median visual acuity was 0.89 (Snellen equivalent, 20/159) (interquartile range, 0.38-1.38; Snellen equivalent, 20/40-20/577) (P = .44). One patient had hand motion acuity.
Figure 3.
Figure 3.. Cumulative logMAR Visual Acuity (VA) of the Aphakia and Intraocular Lens (IOL) Groups at Age 10.5 Years
Cumulative VA in patients with hand motion acuity (defined as logMAR, 2.64) was 2 (2%); light perception acuity (defined as logMAR, 2.78), 1 (1%); and no light perception (defined as logMAR, 2.93), 1 (1%).
Figure 4.
Figure 4.. LogMAR Visual Acuity (VA) of Untreated Eyes at Age 10.5 Years
The number above each bar refers to the number of patients in this acuity category. Median visual acuity was 0.02 (20/21) (interquartile range, −0.06-0.08) (Snellen equivalent, 20/17-20/24) and −0.02 (20/19) (interquartile range, −0.08-0.08) (Snellen equivalent, 20/17-20/24) for the aphakia and intraocular lens (IOL) group, respectively (P = 44).
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Comment in

References

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