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 growing 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 Vi years test and will be 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 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 (DCC) (U10 EY013287, Michael Lynn, PI). The purpose of this grant application is to request the additional funding for the DCC. The DCC will carry out the following aspects of lATS: 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

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)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10EY013287-11A1
Application #
8552196
Study Section
Special Emphasis Panel (ZEY1-VSN (03))
Program Officer
Everett, Donald F
Project Start
2000-12-01
Project End
2015-08-31
Budget Start
2013-09-30
Budget End
2014-08-31
Support Year
11
Fiscal Year
2013
Total Cost
$1
Indirect Cost
$107,679
Name
Emory University
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
066469933
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
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
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
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
Celano, Marianne; Cotsonis, George A; Hartmann, E Eugenie et al. (2016) Behaviors of children with unilateral vision impairment in the Infant Aphakia Treatment Study. J AAPOS 20:320-5
Chaturvedi, Seemant; Turan, Tanya N; Lynn, Michael J et al. (2015) Do Patient Characteristics Explain the Differences in Outcome Between Medically Treated Patients in SAMMPRIS and WASID? Stroke 46:2562-7
Freedman, Sharon F; Lynn, Michael J; Beck, Allen D et al. (2015) Glaucoma-Related Adverse Events in the First 5 Years After Unilateral Cataract Removal in the Infant Aphakia Treatment Study. JAMA Ophthalmol 133:907-14

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