Intraocular lenses (IOLs) are now the accepted treatment following cataract surgery in older children and are being used increasingly in younger children and infants, but little is known about the safety or efficacy of IOLs for a rapidly growin eye. The objective of the Infant Aphakia Treatment Study (IATS) is to compare the relative efficacy and safety of IOL correction versus contact lens correction in infants with a unilateral congenital cataract removed between the ages of 1 to 7 months. We enrolled 114 patients in IATS between December 2004 and January 2009. Phase 1 of the IATS involved following all patients to one year of age so that grating acuity could be assessed with Teller Acuity cards and was completed in January 2010. Phase 2 of IATS involved following all patients to 5 years of age and assessing optotype acuity with the HOTV test at age 4 1/2 years test and was completed in early 2014. We are now requesting additional funding to perform one more clinical examination of these patients at age 10 years so that the incidence of glaucoma after a longer- term follow-up can be compared between the two treatment groups. In addition, we will characterize myopic shift by 10 years in IOL group and identify baseline risk factors such as age of cataract surgery and axial length and other factors that arise during childhood, such as amblyopia and glaucoma, that are associated with a larger than expected myopic shift. The public health importance of this clinical trial not only impacts the approximately 400 children born each year in the United States with a unilateral congenital cataract, but also the 200,000 children worldwide who are blind from cataracts. Phases 1 and 2 of the IATS are funded through two grants, one for the Chairman's Office and one for the Data Coordinating Center (DCC). The purpose of this grant application is to request the additional funding for the DCC for Phase 3. The DCC will carry out the following aspects of IATS: study design, data management, adverse event and patient safety monitoring, statistical reporting and analysis, clinical center monitoring, patient tracking, and trial administration.

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.

National Institute of Health (NIH)
National Eye Institute (NEI)
Clinical Research Cooperative Agreements - Single Project (UG1)
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Special Emphasis Panel (ZEY1-VSN (01))
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Everett, Donald F
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Emory University
Biostatistics & Other Math Sci
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United States
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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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