The convergence insufficiency treatment trial: design, methods, and baseline data.
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) office-based vergence/accommodative therapy with home reinforcement, 4) office-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 9Delta exophoria at near (+/- 4.4) and 2Delta 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).


CONCLUSIONS
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.
Pennsylvania College of Optometry, 1200 West Godfrey Ave, Philadelphia, PA 19141, USA. mscheiman@pco.edu
D000065:Accommodation, Ocular; D000293:Adolescent; D002648:Child; D003290:Convergence, Ocular; D004608:Eligibility Determination; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D008297:Male; D015835:Ocular Motility Disorders / Q000453:epidemiology / Q000503:physiopathology / Q000628:therapy*; D009801:Oculomotor Muscles / Q000503:physiopathology; D009988:Orthoptics / Q000379:methods*; D011446:Prospective Studies; D012107:Research Design; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D015348:Vision, Binocular / Q000502:physiology