This proposal is for the Southern California College of Optometry (SCCO) to serve as 1 of 9 clinical centers for the Convergence Insufficiency Treatment Trial (CITT). The CITT is a multi-center randomized trial designed to compare the effectiveness of 2 active treatment modalities for patients with convergence insufficiency (CI), a distinct disorder of ? binocular vision affecting approximately 5% of children and young adults in the United States. The treatments, pencil push-up therapy and vision therapy/orthoptics, are significantly different in cost and number of office visits required, with pencil push-ups being significantly less costly in time and money. ? In the proposed clinical trial, 392 patients with symptomatic CI between the ages of 9 and 30 years will be randomly assigned to: (1) office-based vision therapy/orthoptics, (2) a control (placebo office-based vision therapy/orthoptics), 3) standard home-based pencil push-up therapy, and 4) office-based pencil push-up therapy. Signs and symptoms of CI will be measured by a masked examiner at baseline and after every 4 weeks of treatment during a 12-week treatment phase. The primary outcome measure is the score from the CITT Symptom Survey at the end of the 12-week treatment phase. Secondary outcome measures are the near point of convergence and positive fusional vergence at near. ? Successfully treated patients will be followed for an additional 12 months to evaluate the long-term persistence of symptomatic relief and improved clinical findings. This application documents SCCO's ability to serve as a CITT Clinical Center and meet its objectives which include: (1) recruiting and enrolling at least 45 eligible patients within the 24-month recruitment period, (2) recruiting ? Hispanic/Latino and Asian patients to ensure ethnic/racial diversity, (3) following the CITT recruitment, randomization, examination, treatment, and follow-up protocols for each patient, (4) maintaining patient and examiner masking, and (5) striving for study visits to be completed within the visit windows, with no missed visits and no loss to follow up, and (6) retaining successfully treated patients for an additional 12 month follow-up period. In addition, documentation is contained herein that the SCCO Clinical Center has appropriate personnel, facilities, and equipment to conduct the study in accordance with the CITT Manual of Procedures. Complete details of the rationale, design, and methods are contained in the applications submitted by the Study Chair and Data Coordinating Center and the Manual of Procedures, which have been submitted separately. ? ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY014709-02
Application #
6954638
Study Section
Special Emphasis Panel (ZEY1-VSN (10))
Program Officer
Miskala, Paivi
Project Start
2004-09-30
Project End
2008-08-31
Budget Start
2005-09-01
Budget End
2006-08-31
Support Year
2
Fiscal Year
2005
Total Cost
$192,904
Indirect Cost
Name
Southern California College of Optometry
Department
Ophthalmology
Type
Schools of Optometry/Ophthalmol
DUNS #
073596710
City
Fullerton
State
CA
Country
United States
Zip Code
92831
Bade, Annette; Boas, Mark; Gallaway, Michael et al. (2013) Relationship between clinical signs and symptoms of convergence insufficiency. Optom Vis Sci 90:988-95
Borsting, Eric; Mitchell, G Lynn; Kulp, Marjean Taylor et al. (2012) Improvement in academic behaviors after successful treatment of convergence insufficiency. Optom Vis Sci 89:12-8
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
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
Rouse, Michael; Borsting, Eric; Mitchell, G Lynn et al. (2009) Academic behaviors in children with convergence insufficiency with and without parent-reported ADHD. Optom Vis Sci 86:1169-77
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