Congenital cataracts are one of the leading causes of blindness among children. For children born with a unilateral cataract, early surgical intervention and consistent optical correction and patching therapy are critical to achieve good vision in this eye. Glaucoma continues to be one of the most serious long term complications in eyes undergoing cataract surgery during early infancy. The Infant Aphakia Treatment Study (IATS) was designed to compare the visual acuity of children after unilateral congenital cataract surgery randomized to either intraocular lens (IOL) or contact lens (CL) correction. Enrollment and randomized treatment of the target sample size of 114 patients (IOL, n=57; CL, n=57) began in December 2004 and was completed in January 2009. We found that the optotype acuity was not significantly different between the study eyes in the two treatment groups at age 41/2 years (p=.54). However, at the full clinical assessment performed at age 5 years, we found that significantly more study eyes in the IOL group had had at least 1 adverse event (p=.02) and at least 1 additional intraocular surgery (p<.001). We also noted that the cumulative incidence of a diagnosis of glaucoma was similar in study eyes in both treatment groups at age 5 years (IOL group, 19%; CL group, 16%). However, using the combined diagnosis glaucoma or glaucoma suspect status, there was a trend noted for more study eyes in the CL group to be affected between ages 1 and 5 years compared to the IOL group (IOL group, 28%; CL group, 35%). In this renewal application for years 13-16 of the IATS, we are proposing to examine these children one more time, in their 10th year (Phase 3), to further elucidate the relationship between initial optical correction, an IOL or a CL, and the incidence of glaucoma. In addition, we will better characterize the longer term myopic shift that occurs in the eyes randomized to primary IOL implantation.

Public Health Relevance

Congenital cataracts are one of the leading causes of blindness among children and glaucoma is one of the most serious adverse events that can develop after cataract surgery during infancy. This study will evaluate whether implantation of an intraocular lens during infantile cataract surgery is associated with a lower long-term incidence of glaucoma than leaving the eye aphakic.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Clinical Research Cooperative Agreements - Single Project (UG1)
Project #
5UG1EY025553-03
Application #
9354491
Study Section
Special Emphasis Panel (ZEY1)
Program Officer
Everett, Donald F
Project Start
2015-09-01
Project End
2019-08-31
Budget Start
2017-09-01
Budget End
2018-08-31
Support Year
3
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Emory University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
066469933
City
Atlanta
State
GA
Country
United States
Zip Code
30322
Koo, Euna B; VanderVeen, Deborah K; Lambert, Scott R (2018) Global Practice Patterns in the Management of Infantile Cataracts. Eye Contact Lens 44 Suppl 2:S292-S296
Cromelin, Caroline H; Drews-Botsch, Carolyn; Russell, Buddy et al. (2018) Association of Contact Lens Adherence With Visual Outcome in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol 136:279-285
Weakley Jr, David R; Lynn, Michael J; Dubois, Lindreth et al. (2017) Myopic Shift 5 Years after Intraocular Lens Implantation in the Infant Aphakia Treatment Study. Ophthalmology 124:822-827
Traboulsi, Elias I; Freedman, Sharon F; Wilson Jr, M Edward et al. (2017) Cataract morphology and risk for glaucoma after cataract surgery in infants with unilateral congenital cataract. J Cataract Refract Surg 43:1611-1612
Russell, Buddy; DuBois, Lindreth; Lynn, Michael et al. (2017) The Infant Aphakia Treatment Study Contact Lens Experience to Age 5 Years. Eye Contact Lens 43:352-357
Weakley, David; Cotsonis, George; Wilson, M Edward et al. (2017) Anisometropia at Age 5 Years After Unilateral Intraocular Lens Implantation During Infancy in the Infant Aphakia Treatment Study. Am J Ophthalmol 180:1-7
Wilson, M Edward; Trivedi, Rupal H; Weakley Jr, David R et al. (2017) Globe Axial Length Growth at Age 5 Years in the Infant Aphakia Treatment Study. Ophthalmology 124:730-733
Bothun, Erick D; Lynn, Michael J; Christiansen, Stephen P et al. (2016) Strabismus surgery outcomes in the Infant Aphakia Treatment Study (IATS) at age 5 years. J AAPOS 20:501-505
Lambert, Scott R; Cotsonis, George; DuBois, Lindreth et al. (2016) Comparison of the rate of refractive growth in aphakic eyes versus pseudophakic eyes in the Infant Aphakia Treatment Study. J Cataract Refract Surg 42:1768-1773
Lambert, Scott R (2016) The timing of surgery for congenital cataracts: Minimizing the risk of glaucoma following cataract surgery while optimizing the visual outcome. J AAPOS 20:191-2

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