Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART)

Principal Investigator:

Mitchell Scheiman, Salus University

Carolyn Denton, Ph.D., University of Texas Health Science Center at Houston (UTHealth)

PIs at each of the nine additional research sites

Funding Agency:

National Eye Institute of the National Institutes of Health

Description of Project:

The purpose of the CITT-ART study is to evaluate the effects of office-based therapy with home reinforcement on reading and attention outcomes for children with symptomatic Convergence Insufficiency (CI), a vision disorder. Children with symptomatic CI report significantly more symptoms when reading and doing close work (e.g., blurred vision, headaches, double vision, loss of concentration, frequent loss of place, trouble remembering what was read), have more behaviors that lead to academic difficulties (e.g., difficulty finishing assignments), and score worse on parent ratings of attention compared to children with normal binocular vision. There is evidence that the symptoms and adverse academic behaviors associated with CI can be reduced through treatment. The CITT-ART study tests the hypothesis that reducing or eliminating these symptoms and behaviors will lead to improved reading performance and attention.

Research Procedures:

CITT-ART is a multicenter, placebo-controlled, randomized clinical trial. Participants are randomly assigned to receive 16 weeks of treatment with either (a) office-based vergence/accommodative therapy with home reinforcement or (b) office-based placebo therapy with home reinforcement. Reading and attention outcomes are assessed at baseline and after 16 weeks of treatment. In addition, the study tests the long-term effects on outcomes at 1 year after treatment completion. 

Role of UTHealth in the Study:

The UTHealth site does not participate in subject recruitment or data collection. The CITT-ART Reading Center, led by Dr. Denton at the CLI, checks the administration and scoring of all of the reading assessments that are administered in the study. Dr. Denton’s team is responsible for ensuring the quality and accuracy of the administration and scoring of reading tests administered at nine study sites located across the country. The sites make audio recordings of assessment sessions and send the assessment materials to UTHealth, where Dr. Denton’s research staff listen to the recordings and re-score all of the tests.

Research Participants:

No participants are being recruited at UTHealth. Participants in the overall study are 324 children ages 9 to <14 years (Grades 3-8) with symptomatic Convergence Insufficiency.

Research Site:

Advanced Vision Center, Schaumburg, IL

Akron Children’s Hospital, Akron, OH

Bascom Palmer Eye Institute, University of Miami, Miami, FL

Marshall B Ketchum University, Fullerton, CA

Nova Southeastern University, Fort Lauderdale, FL

Ohio State University, Columbus, OH

Salus University, Pittsburgh, PA

State University of New York, New York, NY

University of Alabama School of Medicine at Birmingham, Birmingham, AL

University of Texas Health Science Center (UTHealth), Houston, TX 

Western University of Health Sciences, Pomona, CA 

Timeline:

2015-2017