Convergence Insufficiency Treatment Trial (CITT)

Convergence Insufficiency Clinical Trial

Official title:

Convergence Insufficiency Treatment Trial (CITT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00338611
• Other study ID #: NEI-107
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 15, 2006
• Last updated: March 24, 2010
• Start date: July 2005
• Est. completion date: September 2009

Study information

• Verified date: October 2008
• Source: National Eye Institute (NEI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 221
• Est. completion date: September 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children between the ages of 9 and 17 years with symptomatic convergence insufficiency

• Exophoria at near at least 4? 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Binocular Vision Disorder
• Convergence Insufficiency
• Ocular Motility Disorders
• Vision Disorders

Intervention

Behavioral:
• Home-based Pencil Push-Up Therapy
Exercise in which patients visually followed a small letter on a pencil as they moved the pencil closer to the bridge of their nose
• Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics
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
• Office-based Vision Therapy/Orthoptics
Weekly hour-long sessions of office-based vision therapy with a trained therapist and performed at-home reinforcement exercises
• Placebo Office-based Vision Therapy/Orthoptics
Vision activities designed to simulate office-based therapy

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham School of Optometry	Birmingham	Alabama
United States	The Ohio State University College of Optometry	Columbus	Ohio
United States	NOVA Southeastern University College of Optometry	Ft. Lauderdale	Florida
United States	Southern California College of Optometry	Fullerton	California
United States	Ratner Children's Eye Center	La Jolla	California
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	State University of New York College of Optometry	New York	New York
United States	Pennsylvania College of Optometry	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Convergence Insufficiency Treatment Trial Study Group. Randomized clinical trial of treatments for symptomatic convergence insufficiency in children. Arch Ophthalmol. 2008 Oct;126(10):1336-49. doi: 10.1001/archopht.126.10.1336. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey		12 weeks	No
Secondary	Eyes' ability to converge when performing close work		12 weeks	No

External Links

•   NEI Clinical Studies Database