Overview

This trial is active, not recruiting.

Conditions convergence insufficiency, binocular vision disorder
Treatments home-based pencil push-up therapy, home-based pencil push-ups with computer vision therapy/orthoptics, office-based vision therapy/orthoptics, placebo office-based vision therapy/orthoptics
Phase phase 3
Sponsor National Eye Institute (NEI)
Start date July 2005
End date September 2008
Trial size 221 participants
Trial identifier NCT00338611, NEI-107

Summary

The purposes of the CITT are:

- To determine whether Home-based Pencil Push-up therapy, Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics or Office-based VT/Orthoptics more effective than placebo treatment, and whether there are differences between the three treatments in improving subject symptoms and signs.

- To evaluate whether improvements in outcome measures are still present after one year of observation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment

Primary Outcomes

Measure
Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey
time frame: 12 weeks

Secondary Outcomes

Measure
Eyes' ability to converge when performing close work
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 9 years up to 18 years old.

Inclusion Criteria: - Children between the ages of 9 and 17 years with symptomatic convergence insufficiency - Exophoria at near at least 4Δ greater than at far - Insufficient positive fusional convergence at near - A receded near point of convergence of ≥6 cm break - CI Symptom Survey score ≥16 Exclusion Criteria: - Previous treatment with office-based vision therapy/orthoptics or pencil push-ups - Systemic diseases known to affect accommodation, vergence and ocular motility - Developmental disability, mental retardation, attention deficit hyperactivity disorder (ADHD), or learning disability diagnosis that in the investigator's discretion would interfere with treatment

Additional Information

Official title Convergence Insufficiency Treatment Trial (CITT)
Description Convergence insufficiency is a prevalent and distinct binocular vision disorder. Typical symptoms include double vision, eyestrain, headaches, and blurred vision while reading. It affects approximately 5% of children in the United States, and may have a serious impact on an individual's performance in school, choice of jobs, and quality of life. There is no consensus regarding the most effective treatment for convergence insufficiency. Two commonly prescribed treatments are home-based pencil push-up therapy and office-based vision therapy/orthoptics. Significant differences exist between these two treatment modalities in cost and number of office visits required, with pencil push-up therapy being less expensive and less time intensive. There have been no well-designed studies that have compared the effectiveness of these two treatments. The Convergence Insufficiency Treatment Trial (CITT) is a prospective, masked, placebo-controlled, multi-center clinical trial in which 208 subjects between the ages of 9 to < 18 years will be randomly assigned to: 1) Home-based Pencil Push-Up Therapy, 2) Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics, 3) Office-based Vision Therapy/Orthoptics, or 4) Placebo Office-based Vision Therapy/Orthoptics. The primary outcome measure is a measure of symptoms using a 15-item survey, the CI Symptom Survey. Secondary outcome measures are two common clinical tests of the eyes' ability to converge when performing close work. Patients will be tested at the eligibility examination, and by masked examiners after 4, 8 and 12 weeks of treatment have been completed during the 12-week treatment phase. Long term follow-up will be assessed at 6 and 12 months after the completion of active treatment.
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by National Eye Institute (NEI).