Association of Contact Lens Adherence With Visual Outcome in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial

Abstract

Importance: Although contact lenses have been used for decades to optically correct eyes in children after cataract surgery, there has never been a prospective study looking at contact lens adherence in children with aphakia, to our knowledge.

Objective: To evaluate contact lens adherence and its association with visual outcome in a cohort of children treated for unilateral cataract surgery.

Design, setting, and participants: Secondary analysis of a multicenter randomized clinical trial of 57 infants born from August 22, 2004, to April 25, 2008, who were randomized to 1 of 2 treatments and followed up to age 5 years. Data analysis was performed from August 9, 2016, to December 7, 2017.

Interventions: Unilateral cataract extraction and randomization to implantation of an intraocular lens vs contact lens to correct aphakia.

Main outcomes and measures: Contact lens adherence was assessed by a 48-hour recall telephone interview that was administered every 3 months starting 3 months after surgery to age 5 years. A traveling examiner assessed visual acuity in patients at aged 4.5 years. Adherence to prescribed contact lens use was estimated as the mean percentage of waking hours as reported in 2 or more interviews for each year of life.

Results: Of 57 infants who were randomized to contact lens treatment, 32 (56%) were girls, and 49 (86%) were white. A total of 872 telephone interviews were completed. In year 1, a median of 95% participants wore their contacts lenses nearly all waking hours (interquartile range [IQR], 84%-100%); year 2, 93% (IQR, 85%-99%); year 3, 93% (IQR, 85%-99%); year 4, 93% (IQR, 75%-99%); and year 5, 89% (IQR, 71%-97%). There was a tendency for poorer reported adherence at older ages (F = 3.86, P < .001). No differences were identified when the results were analyzed by sex, insurance coverage, or age at cataract surgery. Using linear regression, children who wore the contact lens for a greater proportion of waking hours during the entire study period tended to have better visual acuity at age 4.5 years, even after accounting for adherence to patching (partial correlation = -0.026; P = .08).

Conclusions and relevance: These results confirm that it is possible to achieve a high level of aphakic contact lens adherence over a 5-year period in children.

Trial registration: clinicaltrials.gov Identifier: NCT00212134.

Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Drews-Botsch reports grants from the National Eye Institute. No other disclosures were reported.

Figures

Figure 1.. CONSORT Diagram for the Infant Aphakia Treatment Study

aOne patient was found to have stretching of the ciliary processes intraoperatively after randomization to the intraocular lens group. The investigator decided that an intraocular lens could not be safely implanted, and the patient’s aphakia was treated with a contact lens. bOne patient had developmental delay and could not complete the HOTV acuity test at age 4.5 years. cTwo patients had a secondary intraocular lens implanted at age 1.3 and 3.0 years after randomization. A third patient had a secondary intraocular lens implanted at 4.7 years after randomization and after the primary end point was assessed but before the last clinical examination at age 5 years.

Figure 2.. Percentage of Waking Hours Spent Wearing Contact Lenses by Age in the Infant Aphakia Treatment Study

The horizontal line in the middle of the box indicates median; the top and bottom borders of the boxes, 75th and 25th percentiles; the whiskers, 2 SD from the median; circles, outliers; and triangles, extreme outliers.

Figure 3.. Visual Acuity and Percentage of Waking Hours Spent Wearing Contact Lenses by Age in the Infant Aphakia Treatment Study

The horizontal line in the middle of the box indicates median; the top and bottom borders of the boxes, 75th and 25th percentiles; the whiskers, 2 SD from median; circles, outliers; and triangles, extreme outliers.