TY - JOUR
T1 - The convergence insufficiency treatment trial
T2 - Design, methods, and baseline data
AU - Scheiman, Mitchell
AU - Mitchell, G. Lynn
AU - Cotter, Susan
AU - Kulp, Marjean
AU - Rouse, Michael
AU - Hertle, Richard
AU - Tamkins, Susanna
AU - Cooper, Jeffrey
AU - Granet, David
AU - Mohney, Brian
AU - Coulter, Rachel
AU - Gallaway, Michael
PY - 2008/1
Y1 - 2008/1
N2 - 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 9Δ exophoria at near (+/- 4.4) and 2Δ exophoria (+/-2.8) at distance, CISS score = 30 (+/-9.0), NPC = 14 cm (+/- 7.5), and near positive fusional vergence break = 13 Δ (+/- 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.
AB - 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 9Δ exophoria at near (+/- 4.4) and 2Δ exophoria (+/-2.8) at distance, CISS score = 30 (+/-9.0), NPC = 14 cm (+/- 7.5), and near positive fusional vergence break = 13 Δ (+/- 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.
KW - Computer vergence/accommodative
KW - Convergence insufficiency
KW - Exophoria
KW - Eyestrain
KW - Orthoptics
KW - Pencil push-ups
KW - Placebo
KW - Survey
KW - Symptom
KW - Symptoms
KW - Therapy
KW - Vergence/accommodative therapy
KW - Vision therapy
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U2 - 10.1080/09286580701772037
DO - 10.1080/09286580701772037
M3 - Article
C2 - 18300086
AN - SCOPUS:39749190603
SN - 0928-6586
VL - 15
SP - 24
EP - 36
JO - Ophthalmic Epidemiology
JF - Ophthalmic Epidemiology
IS - 1
ER -