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Accepted (AM)Open Access (License Unspecified), Open
Journal article
The convergence insufficiency treatment trial: Design, methods, and baseline data
Ophthalmic epidemiology, v 15(1), pp 24-36
01 Jan 2008
PMID: 18300086
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Objective: This report describes the design and methodology of the Convergence Insufficiency Treatment Trial (CITT), the first large-scale, placebo-controlled, randomized clinical trial evaluating treatments for convergence insufficiency (CI) in children. We also report the clinical and demographic characteristics of patients. Methods: We prospectively randomized children 9 to 17 years of age to one of four treatment groups: 1) home-based pencil push-ups, 2) home-based computer vergence/accommodative therapy and pencil push-ups, 3) off ice-based vergence/accommodative therapy with home reinforcement, 4) off ice-based placebo therapy. Outcome data on the Convergence Insufficiency Symptom Survey (CISS) score (primary outcome), near point of convergence (NPC), and positive fusional vergence were collected after 12 weeks of active treatment and again at 6 and 12 months posttreatment. Results: The CITT enrolled 221 children with symptomatic CI with a mean age of 12.0 years (SD = +2.3). The clinical profile of the cohort at baseline was 9 Delta exophoria at near (+/-4.4) and 2 Delta exophoria (+/-2.8) at distance, CISS score = 30 (+/-9.0), NPC = 14 cm (+/-7.5), and near positive fusional vergence break = 13 Delta (+/- 4.6). There were no statistically significant nor clinically relevant differences between treatment groups with respect to baseline characteristics (p > 0.05).Conclusion: Hallmark features of the study design include formal definitions of conditions and outcomes, standardized diagnostic and treatment protocols, a placebo treatment arm, masked outcome examinations, and the CISS score outcome measure. The baseline data reported herein define the clinical profile of those enrolled into the CITT.
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Details
- Title
- The convergence insufficiency treatment trial: Design, methods, and baseline data
- Creators
- Mitchell Scheiman - Penn Coll Optometry, Philadelphia, PA 19141 USALynn MitchellSusan CotterMarjean KulpMichael RouseRichard HertleSusanna TamkinsJeffrey CooperDavid GranetBrian MohneyRachel CoulterMichael GallawayCITT Study Grp
- Publication Details
- Ophthalmic epidemiology, v 15(1), pp 24-36
- Publisher
- Taylor & Francis
- Number of pages
- 13
- Grant note
- U10EY014716 / NATIONAL EYE INSTITUTE; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Eye Institute (NEI) U10 EY014709-04; U10 EY014716-02; U10 EY014716-02S1; U10 EY014713-04; U10 EY014659; U10 EY014706-02; U10 EY014712-04; U10 EY014713-01A2; U10 EY014676-04; U10 EY014715-04; U10 EY014712-01A1; U10 EY014713-03; U10 EY014715-03; U10 EY014709-03; U10 EY014706-01A1S1; U10 EY014709-01A1S1; U10 EY014712-02; U10 EY014676; U10 EY014710-04; U10 EY014710-03; U10 EY014715-01A1; U10 EY014713; U10 EY014716-04; U10 EY014709; U10 EY014659-01A2; U10 EY014716; U10 EY014706-01A1; U10 EY014715-01A1S1; U10 EY014716-01A1S1; U10 EY014713-02; U10 EY014706-03; U10 EY014709-01A1; U10 EY014716-01A1; U10 EY014676-01A1S1; U10 EY014715-02; U10 EY014659-02; U10 EY014712-01A1S1; U10 EY014715; U10 EY014676-03; U10 EY014716-03; U10 EY014710-02; U10 EY014676-01A1; U10 EY014659-03; U10 EY014659-04; U10 EY014710-01A1; U10 EY014676-02; U10 EY014710-01A1S1; U10 EY014712; U10 EY014706-04; U10 EY014709-02; U10 EY014712-03 / NEI NIH HHS; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Eye Institute (NEI)
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pennsylvania College of Optometry (PCO)
- Web of Science ID
- WOS:000253584000005
- Scopus ID
- 2-s2.0-39749190603
- Other Identifier
- 991021900190304721
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- Web of Science research areas
- Ophthalmology