This proposal is for the Bascom Palmer Eye Institute of the University of Miami, School of Medicine to serve as a clinical center in the Convergence Insufficiency Treatment Trial (CITT). The CITT is a multi-center randomized clinical trial designed to compare the effectiveness of two active treatment approaches for patients with convergence insufficiency (CI). In the proposed randomized clinical trial 392 patients between the ages of 9 and 30 years will be randomly assigned to: 1) office-based vision therapy/orthoptics, 2) placebo office-based vision therapy/orthoptics, 3) standard home-based pencil push-up therapy, and 4) office-based pencil push-up therapy. Measurements of the signs and symptoms of CI will be made at baseline, and by masked examiners every 4 weeks during the 12-week treatment phase. Patients who are successful after 12 weeks of treatment will be followed for 12 months. The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey. Secondary outcome measures will include the near point of convergence and positive fusional vergence at near. Our objective at the Bascom Palmer Eye Institute is to identify, screen and evaluate potential study participants and to enroll eligible patients in the Convergence Insufficiency Treatment Trial. This application documents the ability of Bascom Palmer Eye Institute to enroll at least 45 patients within the 24 month recruitment period, and to retain each successfully treated patient for one year after completion of treatment. Documentation is also provided to confirm the Bascom Palmer Eye Institute has the personnel, equipment, facilities and clinical trials experience to conduct the study in accordance with the CITT Manual of Procedures (MOP). Complete details of the CITT rationale, design, and methods are contained in the MOP, which is submitted separately with the Study Chair and Data Coordinating Center applications. In addition to the Bascom Palmer Eye Institute, there will be 8 other clinical centers with the Study Chair at the Pennsylvania College of Optometry and the Data Coordinating Center at The Ohio State University. ? ?
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| Barnhardt, Carmen; Cotter, Susan A; Mitchell, G Lynn et al. (2012) Symptoms in children with convergence insufficiency: before and after treatment. Optom Vis Sci 89:1512-20 |
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| Kulp, Marjean; Mitchell, G Lynn; Borsting, Eric et al. (2009) Effectiveness of placebo therapy for maintaining masking in a clinical trial of vergence/accommodative therapy. Invest Ophthalmol Vis Sci 50:2560-6 |
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| Rouse, Michael; Borsting, Eric; Mitchell, G Lynn et al. (2009) Validity of the convergence insufficiency symptom survey: a confirmatory study. Optom Vis Sci 86:357-63 |
| Convergence Insufficiency Treatment Trial (CITT) Study Group (2008) The convergence insufficiency treatment trial: design, methods, and baseline data. Ophthalmic Epidemiol 15:24-36 |
| Convergence Insufficiency Treatment Trial Study Group (2008) Randomized clinical trial of treatments for symptomatic convergence insufficiency in children. Arch Ophthalmol 126:1336-49 |
