The Infant Aphakia Treatment Study was a multicenter randomized clinical trial designed to compare primary intraocular lens (IOL) implantation versus traditional contact lens correction of aphakia in babies undergoing surgery for unilateral congenital cataract at ages younger than 7 months.1 Participants were enrolled from 2004 through 2009, with the last 5-year follow-up examination completed in 2014 and the last 10-year follow-up examination completed in 2019. The study design was approved by the institutional review boards at the 12 study centers, followed the tenets of the Declaration of Helsinki, and complied with the Health Insurance Portability and Accountability Act. The off-label use of the AcrySof SN60AT and MA60AC IOLs (Alcon Laboratories, Fort Worth, TX) was covered by United States Food and Drug Administration investigational device exemption number G020021. Informed consent was obtained from all parents or guardians. The trial is registered at www.ClinicalTrials.gov (identifier, NCT00212134).
In the first year of follow-up, a significant difference was found in the number of complications in the 2 treatment groups that resulted in 36 additional unplanned intraocular surgeries in the IOL group versus only 7 in the aphakia group.2 At the 5-year follow-up at 5 years of age, the study reported that the visual acuity in the 2 groups was not different, but that the number of complications and additional intraocular surgeries required remained much higher in the IOL group.3 This led the authors to make the recommendation, based on the 5-year follow-up data, that babies with unilateral cataract typically should not have an IOL implanted in the first 6 months of life, provided the caretakers are thought to be capable of contact lens care, and absent other extenuating circumstances that would alter the risk-to-benefit ratio.
The purpose of this report is to describe the complications, adverse events, and additional surgeries that each of the 2 study groups experienced between the 5- and 10-year follow-up examinations. The intent was to determine whether this longer follow-up might alter the study group recommendations made 5 years earlier. Of the original 114 patients enrolled in the study, 110 were available for the 10-year follow-up examination at an average age of 10.6 years.
Adverse events that occurred during the 6- to 10-year follow-up period included glaucoma, suspected glaucoma, lens reproliferation into the visual axis, corectopia, retinal detachment, and contact lens-related complications. With the exception of patients newly diagnosed with glaucoma or considered to be glaucoma suspects, the number of adverse events occurring between years 6 and 10 was very small.
One patient in the IOL group demonstrated a visual axis opacity at 7 years of age, which was cleared concurrently with an IOL exchange. One IOL patient demonstrated a retinal detachment in the pseudophakic eye at 10 years of age. Notably, this patient was diagnosed with Stickler syndrome during the study follow-up and had been found to have a refraction of e17.50 D in the phakic eye at 2 years of age. Five additional IOL patients were reported to have corectopia, but none of these cases were considered visually significant or required intervention. Only 1 patient in the aphakia group reported a complication, which was a corneal abrasion related to contact lens use. As expected, more children were diagnosed with glaucoma or as glaucoma suspects in the operated eye between 6 and 10 years of age. During this period, 4 children in the aphakia group were diagnosed with glaucoma, bringing the total number of patients diagnosed by 10 years of age to 13. An additional 2 children were diagnosed as glaucoma suspects, bringing this total to 13 also. In the IOL group, 1 child was diagnosed with glaucoma and another 7 were diagnosed as glaucoma suspects between 6 and 10 years of age, bringing the 10-year totals to 12 children with glaucoma and 8 glaucoma suspects. Overall by 10 years of age, 26 (47%) children in the aphakia group had been diagnosed with glaucoma or as glaucoma suspects versus 20 (36%) in the IOL group (P = 0.33).
Data were collected on all ocular surgeries occurring after the original cataract operation, regardless of whether they were related to the original intervention. Only intraocular surgeries are reported here. Table 1 shows the additional intraocular surgeries that were performed in each of the 2 study groups during each of the 3 study periods. Twenty-six additional nonglaucoma intraocular surgeries took place during the 6- to 10-year follow-up period.
Table 1.
Additional Intraocular Surgeries at Year 1, Years 2 through 5, and Years 6 through 10
| Contact Lens Group by Years |
Intraocular Lens Group by Years |
|||||
|---|---|---|---|---|---|---|
| Surgical Procedure | 1 | 2–5 | 6–10 | 1 | 2–5 | 6–10 |
| Clearing visual axis opacities | 6 | 3 | 0 | 34 | 8 | 0 |
| Glaucoma surgery | 1 | 1 | 4 | 4 | 2 | 1 |
| Repair retinal detachment | 2 | 0 | 0 | 0 | 0 | 1 |
| Repair wound dehiscence | 0 | 0 | 0 | 1 | 0 | 0 |
| IOL exchange | n/a | n/a | n/a | 1 | 2 | 4 |
| Iridectomy or iridotomy | 1 | 0 | 0 | 1 | 0 | 0 |
| Lysis of vitreous wick | 0 | 0 | 0 | 1 | 0 | 0 |
| Secondary IOL | 0 | 3 | 21 | n/a | n/a | n/a |
| No. of patients with at least 1 procedure | 7 | 7 | 25 | 36 | 8 | 6 |
IOL intraocular lens; n/a not applicable.
In the aphakia group, 21 secondary IOLs were placed (secondary IOL placement was allowed during the study at investigator discretion). Four children in the IOL group underwent IOL exchanges because of the development of highly myopic refractive errors. One patient in the IOL group, mentioned previously, underwent surgery for retinal reattachment. Five children underwent glaucoma surgery, 4 in the aphakia group and 1 in the IOL group. The surgeries included 2 trabeculotomies, 2 glaucoma drainage device procedures, and 1 trabeculectomy. Overall, at 10 years of follow-up, the IOL group had undergone more additional intraocular surgeries (n = 71) than the aphakia group (n = 38), although the difference was less than it was at the 5-year follow-up (66 surgeries vs. 17 surgeries).
In summary, years 6 through 10 of follow-up in children undergoing surgery for unilateral congenital cataract in the first 6 months of life found more cases of glaucoma diagnosed, many aphakic children electing to undergo secondary IOL implantation, and a growing number of pseudophakic children requiring IOL exchange because of the development of highly myopic refractive errors. Only 1 visually significant complication among the 110 children occurred between 6 and 10 years of age: a retinal detachment in a child with Stickler syndrome. Overall, this report helps to confirm the longer-term safety of IOL use in young children and also supports the recommendation made by this study group after 5 years of follow-up that babies aged younger than 7 months with unilateral cataract typically be left aphakic after cataract surgery.
Acknowledgments
Supported by the National Institutes of Health, Bethesda, Maryland (grant nos. U10EY13272, U10EY013287, and EY06360); and Research to Prevent Blindness, Inc., New York, New York.
HUMAN SUBJECTS: Human subjects were included in this study. The study design was approved by the institutional review boards at the 12 study centers (Medical University of South Carolina; Harvard University, Boston, MA; University of Minnesota, Minneapolis, MN; Cleveland Clinic, Cleveland, OH; Baylor College of Medicine, Houston, TX; Oregon Health and Science University, Portland, OR; Emory University; Duke University; Vanderbilt University, Nashville, TN; Indiana University, Indianapolis, IN; Miami Children’s Hospital, Miami, FL; University of Texas Southwestern, Dallas, TX), followed the tenets of the Declaration of Helsinki, and complied with the Health Insurance Portability and Accountability Act. All participants’ parents or guardians provided informed consent.
No animal subjects were included in this study.
Footnotes
Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
References
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