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
Felius, Joost; Busettini, Claudio; Lynn, Michael J et al. (2014) Nystagmus and related fixation instabilities following extraction of unilateral infantile cataract in the Infant Aphakia Treatment Study (IATS). Invest Ophthalmol Vis Sci 55:5332-7
Infant Aphakia Treatment Study Group; Lambert, Scott R; Lynn, Michael J et al. (2014) Comparison of contact lens and intraocular lens correction of monocular aphakia during infancy: a randomized clinical trial of HOTV optotype acuity at age 4.5 years and clinical findings at age 5 years. JAMA Ophthalmol 132:676-82
Trivedi, Rupal H; Lambert, Scott R; Lynn, Michael J et al. (2014) The role of preoperative biometry in selecting initial contact lens power in the Infant Aphakia Treatment Study. J AAPOS 18:251-4
Bothun, Erick D; Cleveland, Julia; Lynn, Michael J et al. (2013) One-year strabismus outcomes in the Infant Aphakia Treatment Study. Ophthalmology 120:1227-31
Carrigan, Anna K; DuBois, Lindreth G; Becker, Edmund R et al. (2013) Cost of intraocular lens versus contact lens treatment after unilateral congenital cataract surgery: retrospective analysis at age 1 year. Ophthalmology 120:14-9
Celano, Marianne; Hartmann, Eugenie E; Drews-Botsch, Carolyn D et al. (2013) Parenting stress in the infant aphakia treatment study. J Pediatr Psychol 38:484-93
Vanderveen, Deborah K; Trivedi, Rupal H; Nizam, Azhar et al. (2013) Predictability of intraocular lens power calculation formulae in infantile eyes with unilateral congenital cataract: results from the Infant Aphakia Treatment Study. Am J Ophthalmol 156:1252-1260.e2
Drews-Botsch, Carolyn D; Celano, Marianne; Kruger, Stacey et al. (2012) Adherence to occlusion therapy in the first six months of follow-up and visual acuity among participants in the Infant Aphakia Treatment Study (IATS). Invest Ophthalmol Vis Sci 53:3368-75
Beck, Allen D; Freedman, Sharon F; Lynn, Michael J et al. (2012) Glaucoma-related adverse events in the Infant Aphakia Treatment Study: 1-year results. Arch Ophthalmol 130:300-5
Plager, David A; Lynn, Michael J; Buckley, Edward G et al. (2011) Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study. Ophthalmology 118:2330-4

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