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Original Investigation
December 17, 2020

Glaucoma-Related Adverse Events at 10 Years in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial

Author Affiliations
  • 1Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina
  • 2Department of Ophthalmology, Emory University School of Medicine, Atlanta, Georgia
  • 3Department of Biostatistics and Bioinformatics, Rollins School of Public Health of Emory University, Atlanta, Georgia
  • 4Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts
  • 5Department of Ophthalmology, Indiana University School of Medicine, Indianapolis
  • 6Department of Ophthalmology and Visual Sciences, Vanderbilt University Medical Center, Nashville, Tennessee
  • 7Department of Ophthalmology, Stanford University School of Medicine, Palo Alto, California
JAMA Ophthalmol. 2021;139(2):165-173. doi:10.1001/jamaophthalmol.2020.5664
Key Points

Question  What is the 10-year cumulative incidence of glaucoma and glaucoma suspect after removal of unilateral cataract in infancy in the Infant Aphakic Treatment Study, and how is the retinal nerve fiber layer and optic nerve head appearance affected?

Findings  In this secondary analysis of a randomized clinical trial, risk of glaucoma and glaucoma plus glaucoma suspect diagnosis at 10 years rose to 22% and 40%, respectively, with no difference between treatment groups (primary intraocular lens vs aphakia). Eyes with glaucoma (vs glaucoma suspects or neither) had relatively preserved retinal nerve fiber layer, similar optic nerve head appearance, and visual acuity.

Meaning  The results of this study support the need for lifelong surveillance for glaucoma and glaucoma-related events following cataract removal in infancy.


Importance  Glaucoma-related adverse events constitute serious complications of cataract removal in infancy, yet long-term data on incidence and visual outcome remain lacking.

Objective  To identify and characterize incident cases of glaucoma and glaucoma-related adverse events (glaucoma + glaucoma suspect) among children in the Infant Aphakia Treatment Study (IATS) by the age of 10.5 years and to determine whether these diagnoses are associated with optic nerve head (ONH) and peripapillary retinal nerve fiber layer (RNFL) assessment.

Design, Setting, and Participants  Analysis of a multicenter randomized clinical trial of 114 infants with unilateral congenital cataract who were aged 1 to 6 months at surgery. Data on long-term glaucoma-related status and outcomes were collected when children were 10.5 years old (July 14, 2015, to July 12, 2019) and analyzed from March 30, 2019, to August 6, 2019.

Interventions  Participants were randomized at cataract surgery to either primary intraocular lens (IOL), or aphakia (contact lens [CL]). Standardized definitions of glaucoma and glaucoma suspect were created for IATS and applied for surveillance and diagnosis.

Main Outcomes and Measures  Development of glaucoma and glaucoma + glaucoma suspect in operated-on eyes up to age 10.5 years, plus intraocular pressure, axial length, RNFL (by optical coherence tomography), and ONH photographs.

Results  In Kaplan-Meier analysis, for all study eyes combined (n = 114), risk of glaucoma after cataract removal rose from 9% (95% CI, 5%-16%) at 1 year, to 17% (95% CI, 11%-25%) at 5 years, to 22% (95% CI, 16%-31%) at 10 years. The risk of glaucoma plus  glaucoma suspect diagnosis after cataract removal rose from 12% (95% CI, 7%-20%) at 1 year, to 31% (95% CI, 24%-41%) at 5 years, to 40% (95% CI, 32%-50%) at 10 years. Risk of glaucoma and glaucoma plus glaucoma suspect diagnosis at 10 years was not significantly different between treatment groups. Eyes with glaucoma (compared with eyes with glaucoma suspect or neither) had longer axial length but relatively preserved RNFL and similar ONH appearance and visual acuity at age 10 years.

Conclusions and Relevance  Risk of glaucoma-related adverse events continues to increase with longer follow-up of children following unilateral cataract removal in infancy and is not associated with primary IOL implantation. Development of glaucoma (or glaucoma suspect) after removal of unilateral congenital cataract was not associated with worse visual acuity outcomes at 10 years.

Trial Registration  ClinicalTrials.gov Identifier: NCT00212134

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