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
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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