Elsevier

Ophthalmology

Volume 126, Issue 8, August 2019, Pages 1189-1195
Ophthalmology

Original Article
Outcomes of Unilateral Cataracts in Infants and Toddlers 7 to 24 Months of Age: Toddler Aphakia and Pseudophakia Study (TAPS)

Presented as a poster at: American Academy of Ophthalmology Annual Meeting, October 2018, Chicago, Illinois.
https://doi.org/10.1016/j.ophtha.2019.03.011Get rights and content

Purpose

To evaluate outcomes of unilateral cataract surgery in children 7 to 24 months of age.

Design

Retrospective case series at 10 Infant Aphakia Treatment Study (IATS) sites.

Participants

The Toddler Aphakia and Pseudophakia Study is a registry of children treated by surgeons who participated in the IATS.

Methods

Children underwent unilateral cataract surgery with or without intraocular lens (IOL) placement during the IATS enrollment years of 2004 and 2010.

Main Outcome Measures

Intraoperative complications, adverse events (AEs), visual acuity, and strabismus.

Results

Fifty-six children were included with a mean postoperative follow-up of 47.6 months. Median age at cataract surgery was 13.9 months (range, 7.2–22.9). Ninety-two percent received a primary IOL. Intraoperative complications occurred in 4 patients (7%). At 5 years of age, visual acuity of treated eyes was very good (≥20/40) in 11% and poor (≤20/200) in 44%. Adverse events were identified in 24%, with a 4% incidence of glaucoma suspect. An additional unplanned intraocular surgery occurred in 14% of children. Neither AEs nor intraocular reoperations were more common for children with surgery at 7 to 12 months of age than for those who underwent surgery at 13 to 24 months of age (AE rate, 21% vs. 25% [P = 0.60]; reoperation rate, 13% vs. 16% [P = 1.00]).

Conclusions

Although most children underwent IOL implantation concurrent with unilateral cataract removal, the incidence of complications, reoperations, and glaucoma was low when surgery was performed between 7 and 24 months of age and compared favorably with same-site IATS data for infants undergoing surgery before 7 months of age. Our study showed that IOL implantation is relatively safe in children older than 6 months and younger than 2 years.

Section snippets

Methods

This study was approved by the institutional review board or ethics review board at all participating institutions and complied with the Health Insurance Portability and Accountability Act. Data sharing agreements were established between the IATS investigator sites and the Mayo Clinic. All research adhered to the tenets of the Declaration of Helsinki.

Results

A total of 96 children (96 eyes) were registered through 10 IATS sites with a history of unilateral cataract surgery between 2004 and 2010. Two prior IATS clinical sites did not participate because of institutional review board limitations. Thirty eyes were excluded because of disqualifying baseline history or clinical findings, and 10 were not included because their follow-up ended before 4 years of age. Fifty-six children were eligible for review. Seven children in the TAPS registry were

Discussion

The low rate of complications, reoperations, and AEs after unilateral primary IOL implantation in older infants and toddlers (7–24 months of age at surgery) in this registry stands in striking contrast to that reported in IATS infants younger than 7 months at surgery. Despite the limits of retrospective data, the TAPS data are compelling because these procedures were performed through the care of IATS surgeons during the same period as the IATS.

In the early 2000s, a debate arose regarding the

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Supplemental material available at www.aaojournal.org.

Financial Disclosure(s): The author(s) have made the following disclosure(s): M.E.W.: Consultant – EyePoint Pharma; Royalties – Wolters Kluwer.

D.K.V.: Financial support – Retrophin, Inc.; Expert testimony – Franklin Casualty.

A.R.L.: Financial support – Knights Templar.

Supported by the Mayo Clinic, Rochester, Minnesota (CCaTS grant UL1TR000135). The sponsor or funding organization had no role in the design or conduct of this research.

HUMAN SUBJECTS: Human subjects were not included in this study. This retrospective chart review study was approved by the Institutional Review Board (IRB)/Ethics Review Board at all participating institutions (Mayo Clinic, Baylor College of Medicine and Texas Children’s Hospital, Cole Eye Institute, Duke University School of Medicine, Emory University School of Medicine, Harvard University, Indiana University, Medical University of South Carolina, Oregon Health and Science University, University of Minnesota, Vanderbilt University Medical Center) and complies with the Health Insurance Portability and Accountability Act. Data sharing agreements were established between the IATS investigator sites and the Mayo Clinic. All research adhered to the tenets of the Declaration of Helsinki. The written consent requirement was waived due to the retrospective nature of the study.

No animal subjects were included in this study.

Author Contributions:

Conception and design: Bothun, Wilson, Traboulsi, Diehl, Plager, Vanderveen, Freedman, Yen, Weil, Loh, Morrison, Anderson, Lambert

Analysis and interpretation: Bothun, Wilson, Traboulsi, Diehl, Plager, Vanderveen, Freedman, Yen, Weil, Loh, Morrison, Anderson, Lambert

Data collection: Bothun, Wilson, Traboulsi, Diehl, Plager, Vanderveen, Freedman, Yen, Weil, Loh, Morrison, Anderson, Lambert

Obtained funding: Bothun

Overall responsibility: Bothun, Wilson, Traboulsi, Diehl, Plager, Vanderveen, Freedman, Yen, Weil, Loh, Morrison, Anderson, Lambert

Members of the Toddler Aphakia and Pseudophakia Study Group are available at www.aaojournal.org.

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