Intraocular lenses (lOLs) 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 lOLs for a rapidly growin eye. The objective of the Infant Aphakia Treatment Study (lATS) is to compare the relative efficacy and safety of lOL correction versus contact lens correction in infants with a unilateral congenital cataract removed between the ages of 1 to 7 months. The primary outcome of the clinical trial is visual acuity. We enrolled 114 patients in lATS between December 2004 and January 2009. Phase 1 of the lATS 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 lATS involved following all patients to 5 years of age and assessing optotype acuity with the HOTV test at age 4 years. We are now requesting additional funding to perform one more clinical examination of these patients at age 10 years so that the following factors can be compared between the two treatment groups: 1) the primary outcome, visual acuity using the E-ETDRS logMAR chart;and 2) the incidence of glaucoma after a longer-term follow-up. 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. lATS is funded through two grants, one for the Chairman's Office (U10 EY013272, Scott Lambert, PI) and one for the Data Coordinating Center (U10 EY013287, Michael Lynn, PI).

Public Health Relevance

This study is comparing two treatments for an infant born with a cataract in one eye to find out which treatment is better. One treatment is cataract removal with a replacement lens placed inside the eye and glasses. The other treatment is cataract removal and a contact lens.

Agency
National Institute of Health (NIH)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY013272-12
Application #
8739646
Study Section
Special Emphasis Panel (ZEY1)
Program Officer
Everett, Donald F
Project Start
Project End
Budget Start
Budget End
Support Year
12
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Emory University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
City
Atlanta
State
GA
Country
United States
Zip Code
30322
Drews-Botsch, Carolyn; Celano, Marianne; Cotsonis, George et al. (2016) Association Between Occlusion Therapy and Optotype Visual Acuity in Children Using Data From the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol 134:863-9
Kumar, Priyanka; Lambert, Scott R (2016) Evaluating the evidence for and against the use of IOLs in infants and young children. Expert Rev Med Devices 13:381-9
Drews-Botsch, Carolyn; Cotsonis, George; Celano, Marianne et al. (2016) Assessment of Adherence to Visual Correction and Occlusion Therapy in the Infant Aphakia Treatment Study. Contemp Clin Trials Commun 3:158-166
Bothun, Erick D; Lynn, Michael J; Christiansen, Stephen P et al. (2016) Sensorimotor outcomes by age 5 years after monocular cataract surgery in the Infant Aphakia Treatment Study (IATS). J AAPOS 20:49-53
Lee, Yeon-Hee; Lenhart, Phoebe D; Lambert, Scott R (2016) Cataract secondary to self-inflicted blunt trauma in children with autism spectrum disorder. J AAPOS 20:361-2
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
Russell, Buddy; DuBois, Lindreth; Lynn, Michael et al. (2016) The Infant Aphakia Treatment Study Contact Lens Experience to Age of 5 Years. Eye Contact Lens :
Celano, Marianne; Hartmann, E Eugenie; DuBois, Lindreth G et al. (2016) Motor skills of children with unilateral visual impairment in the Infant Aphakia Treatment Study. Dev Med Child Neurol 58:154-9
Traboulsi, E I; Vanderveen, D; Morrison, D et al. (2016) Associated systemic and ocular disorders in patients with congenital unilateral cataracts: the Infant Aphakia Treatment Study experience. Eye (Lond) 30:1170-4
Lambert, S R; DuBois, L; Cotsonis, G et al. (2016) Factors associated with stereopsis and a good visual acuity outcome among children in the Infant Aphakia Treatment Study. Eye (Lond) 30:1221-8

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