Convergence Insufficiency Treatment Trial (CITT)

Convergence Insufficiency Treatment Trial (CITT)

Sponsors

Lead Sponsor: National Eye Institute (NEI)

Source National Eye Institute (NEI)
Brief 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.

Detailed 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.

Overall Status Unknown status
Start Date July 2005
Completion Date September 2009
Primary Completion Date September 2008
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey 12 weeks
Secondary Outcome
Measure Time Frame
Eyes' ability to converge when performing close work 12 weeks
Enrollment 221
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Home-based Pencil Push-Up Therapy

Description: Exercise in which patients visually followed a small letter on a pencil as they moved the pencil closer to the bridge of their nose

Intervention Type: Behavioral

Intervention Name: Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics

Description: Exercise in which patients visually followed a small letter on a pencil as they moved the pencil closer to the bridge of their nose combined with additional computer vision therapy

Intervention Type: Behavioral

Intervention Name: Office-based Vision Therapy/Orthoptics

Description: Weekly hour-long sessions of office-based vision therapy with a trained therapist and performed at-home reinforcement exercises

Intervention Type: Behavioral

Intervention Name: Placebo Office-based Vision Therapy/Orthoptics

Description: Vision activities designed to simulate office-based therapy

Eligibility

Criteria:

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

Gender: All

Minimum Age: 9 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mitchell Scheiman, OD Study Chair Pennsylvania College of Optometry
Location
Facility:
University of Alabama at Birmingham School of Optometry | Birmingham, Alabama, 35294, United States
Southern California College of Optometry | Fullerton, California, 92093, United States
Ratner Children's Eye Center | La Jolla, California, 92093, United States
NOVA Southeastern University College of Optometry | Ft. Lauderdale, Florida, 33328, United States
Bascom Palmer Eye Institute | Miami, Florida, 33136, United States
Mayo Clinic | Rochester, Minnesota, 55905, United States
State University of New York College of Optometry | New York, New York, 10036, United States
The Ohio State University College of Optometry | Columbus, Ohio, 43210, United States
Pennsylvania College of Optometry | Philadelphia, Pennsylvania, 19141, United States
Location Countries

United States

Verification Date

October 2008

Responsible Party

Name Title: Mitchell Scheiman, OD

Organization: Pennsylvania College of Optometry

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov