1.6.2 Data Coordinating Center
Location: The Ohio State University Optometry Coordinating Center, Columbus, OH
The Coordinating Center will:
Provide epidemiologic and biostatistical expertise to the organization, design, conduct, and analysis of the trial
Be responsible for quality assurance procedures
Develop and refine the study Manual of Procedures
Develop and distribute study forms, documents, and protocols
Provide independent and objective confirmation of subject eligibility
Develop and monitor the randomization process
Develop and implement procedures for data management and data analysis
Prepare periodic monitoring reports for the trial’s Executive Committee, Data and Safety Monitoring Committee, and the National Eye Institute
Archive all study documents
Serve on the Executive Committee
Participate in site visits
Participate in the design, analysis, and publication of the study results
1.6.3 Clinic Sites
Locations: (See page 1-12)
The Clinic Sites are responsible for:
Collaborating in the development of relevant sections of the Manual of Procedures
Collaborating in the development of study forms and procedure
Developing informed consent procedures
Obtaining local IRB approval
All aspects of subject recruitment
Data collection for all study visits
Training and supervision of staff involved with data collection
1.6.4 National Eye Institute
The National Eye Institute is accountable for the use of Institute funds and participates to ensure the success of the study. The NEI Grants Management Specialist is responsible for all business management matters associated with administration of the CITT. The NEI Program Director, Päivi Miskala, PhD, participates in all scientific activities of the study and provides assistance in study administration. All questions or correspondence dealing with research progress, changes in research direction, unique scientific opportunities, or any other scientific needs should be addressed to Dr. Miskala.
1.7 Study Committees
CITT committees include the Executive Committee and the Data and Safety Monitoring Committee. The composition and functions of each committee are described below.
1.7.1 Executive Committee (EC)
The CITT EC, which oversees and directs all aspects of the study, includes: Mitchell Scheiman, OD, CITT Study Chair, Pennsylvania College of Optometry
G. Lynn Mitchell, MAS, DCC Principal Investigator, The Ohio State University College of Optometry Susan Cotter, OD, Vice-Chair, Southern California College of Optometry Richard Hertle, MD, Vice-Chair, Children’s Hospital of Pittsburgh Marjean Taylor-Kulp, OD, PI, The Ohio State University College of Optometry Michael Rouse, OD, Study Consultant, Southern California College of Optometry Maryann Redford, DDS MPH, NEI Program Director
Executive Committee functions are to:
Provide overall direction and coordination for the trial
Supervision of training and certification
Review study progress
Formulate policies and decisions for the trial
Review and approve the procedures for the conduct of the trial
Resolve technical issues
Interact with the DSMC regarding the conduct of the trial and react to its advice regarding the design, operation, or termination of the trial
Coordinate the preparation of progress reports and updates to the MOP
All members of the Executive Committee serve for the duration of the trial, provided they continue in their designated capacities. The Executive Committee will communicate throughout the trial with regularly scheduled conference calls.
1.7.2 Data and Safety Monitoring Committee
The Data and Safety Monitoring Committee consists of members of the scientific community entrusted to ensure the safety of all CITT participants and the validity and integrity of the CITT data.
The committee includes: Marie Diener-West, PhD., Chairman, Professor of Biostatistics, Johns Hopkins University Rev. Andrew Costello, C.Ss.R., St. Mary’s Church, Annapolis, MD William V. Good, M.D., Smith Kettlewell Eye Research Institute Ronald D. Hays, PhD., UCLA Department of Medicine Argye Hillis, PhD., Waco, TX (retired; effective March 2006) Ruth Manny, O.D. PhD., University of Houston College of Optometry
The specific functions of the DSMC include:
Provision of advice to the Executive Committee on operational procedures that would improve the quality of the trial
Review and approval of the protocol
Review of the data collected throughout the trial for evidence of adverse, beneficial or no treatment effects
Provision of advice to the investigators of the study and the NEI on the design, organization, and conduct of the trial
Provision of guidance to NEI as to the continuation or termination of the trial
Monitoring the conduct of the CITT
Reviewing the design of the CITT, including methods of subject recruitment, the informed consent process, and data collection procedures
Evaluating the accumulating data at regular intervals
Determining when the data are sufficiently convincing to answer questions of interest
Monitoring the study data for early dramatic effects or potential harmful effects
Determining when data collected should be released to the Study investigators, to Study subjects, and to the ophthalmic community
Evaluating recruitment and monitoring the overall performance of the CITT Participating Clinics
Recommending to the NEI and the Executive Committee changes in the Study protocol based on periodic data analysis
Evaluating data and protocols for the protection of the participating subjects
Reviewing the results of the CITT and how they will be presented in publication.
Protecting the operational and scientific integrity of the Study including the evaluation of ancillary studies
1.8 References
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Rouse MW, Borsting E, Hyman L, Hussein M, Cotter S, Flynn M, Scheiman M, Gallaway M, De Land PN, CIRS group frequency of convergence insufficiency among fifth and sixth graders. Optom Vis Sci 1999; 9:643-649.
Hirsch AB. A study of forty-eight cases of convergence insufficiency at the near point. Am J Optom Arch Am Acad Optom 1943; 20:52-58.
Mazow ML. The convergence insufficiency syndrome. J Ped Ophthalmol 1971; 8:243-44.
Duke-Elder S and Wybar K. Ocular motility and strabismus. In: Duke-Elder S. System of ophthalmology, Vol 6. St Louis 1973, Mosby, pp 547-551.
Pickwell LD. The significance of inadequate convergence. Ophthal Physiol Opt. 1981; 1:13-18.