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 #
5U10EY013287-09
Application #
8293268
Study Section
Special Emphasis Panel (ZEY1-VSN (08))
Program Officer
Everett, Donald F
Project Start
2004-06-01
Project End
2013-09-29
Budget Start
2012-06-01
Budget End
2013-09-29
Support Year
9
Fiscal Year
2012
Total Cost
$759,095
Indirect Cost
$269,356
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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