The purpose of the Data Coordinating Center (DCC) for the Infant Aphakia Treatment Study (IATS) is to provide design and trial management support for this randomized multicenter clinical trial. In particular, the DCC will be responsible for the following activities: (1) Research Design: The DCC will provide statistical and epidemiological expertise in the design of the study. This includes defining outcomes, choosing the experimental design, estimating sample size and power, determining procedures to control bias, and evaluating the potential impact from any future proposed changes to the study design or procedures. (2) Case Report Forms: The DCC will collaborate with the clinical investigators to design the case report forms. The DCC will produce the case report forms and distribute the forms to the clinical centers. (3) Training: The DCC will train and certify clinical center personnel in non-clinical study procedures. (4) Patient Screening and Randomization: The DCC will design and implement patient screening and randomization procedures. (5) Data Management: The DCC will be responsible for all aspects of data management including data acquisition from the clinical centers, data editing for accuracy and completeness, monitoring completeness of follow-up and contacting centers to correct data problems. (6) Coordination with Visual Acuity Testing Center (VATC): The DCC will coordinate with the VATC on the collection and processing of the visual acuity data. (7) Clinical Center Monitoring: The DCC will conduct auditing visits to the clinical centers to verify the data submitted on CRFs and to check that the protocol is being followed. (8) Patient Tracking: The DCC will assist the clinical centers in tracking the location of patients. (9) Patient Adherence Monitoring: The DCC will place calls to the patients to monitor adherence to the patching protocols. (10) Adverse Event Monitoring: The DCC will monitor the occurrence of adverse events and will report to the Data Safety Monitoring Committee (DSMC) on a regular schedule. (11) Statistical Reporting and Analysis: The DCC will develop statistical reports for the DSMC and other agencies and will determine and carry out appropriate statistical analyses to evaluate study hypotheses.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY013287-08
Application #
8281410
Study Section
Special Emphasis Panel (ZEY1-VSN (08))
Program Officer
Everett, Donald F
Project Start
2004-06-01
Project End
2014-05-31
Budget Start
2011-06-01
Budget End
2012-05-31
Support Year
8
Fiscal Year
2011
Total Cost
$759,095
Indirect Cost
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
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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