Office-based Vision Therapy for Improving Reading and Attention in Children With Convergence Insufficiency

NCT02207517 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2020-03-17

No results posted yet for this study

Summary

CITT-ART is a multicenter study (8 locations around the United States) of 324 children ages 9 to \<14 years with symptomatic convergence insufficiency (CI). The purpose of this study is to see if office-based therapy for convergence insufficiency (CI) improves reading ability and attention. CI is an eye-teaming problem where the eyes would like to drift outward when reading or doing close work. When eyes drift out, double vision can happen. To prevent double vision one must use extra effort to keep the eyes from going out. This extra effort can cause symptoms that can interfere with reading and working comfortably at near. These symptoms often include eyestrain, blurred vision, headaches, double vision, and loss of place when reading or performing tasks at near. In a prior study we found that therapy improves these symptoms. In this study we are looking at whether the therapy improves reading and attention

Conditions

  • Convergence Insufficiency

Interventions

PROCEDURE

Office-based vergence/accommodative therapy

The OBVAT program has been divided into 4 phases. Within each phase there are a number of categories such as gross convergence, vergence, and accommodation. The therapy procedures in each category have been arranged sequentially from easiest to most difficult

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH
  • Marshall B. Ketchum University

    collaborator UNKNOWN
  • Ohio State University

    collaborator OTHER
  • University of Alabama at Birmingham

    collaborator OTHER
  • State University of New York College of Optometry

    collaborator OTHER
  • Akron Children's Hospital

    collaborator OTHER
  • Nova Southeastern University

    collaborator OTHER
  • Bascom Palmer Eye Institute

    collaborator OTHER
  • Salus University

    lead OTHER

Principal Investigators

  • Mitchell Scheiman, OD · Salus University

  • Lynn MItchell, MAS · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-07-31
Completion
2020-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02207517 on ClinicalTrials.gov