Convergence Insufficiency Treatment Trial (CITT)

Sponsor

National Eye Institute (NEI) (NIH)

Overall Status

Unknown status

CT.gov ID

NCT00338611

Collaborator

(none)

221

Enrollment

Locations

Duration (Months)

24.6

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Convergence Insufficiency Binocular Vision Disorder	Behavioral: Home-based Pencil Push-Up Therapy Behavioral: Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics Behavioral: Office-based Vision Therapy/Orthoptics Behavioral: Placebo Office-based Vision Therapy/Orthoptics	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

221 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Convergence Insufficiency Treatment Trial (CITT)

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Sep 1, 2008

Anticipated Study Completion Date :

Sep 1, 2009

Outcome Measures

Primary Outcome Measures

Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey [12 weeks]

Secondary Outcome Measures

Eyes' ability to converge when performing close work [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham School of Optometry	Birmingham	Alabama	United States	35294
2	Southern California College of Optometry	Fullerton	California	United States	92093
3	Ratner Children's Eye Center	La Jolla	California	United States	92093
4	NOVA Southeastern University College of Optometry	Ft. Lauderdale	Florida	United States	33328
5	Bascom Palmer Eye Institute	Miami	Florida	United States	33136
6	Mayo Clinic	Rochester	Minnesota	United States	55905
7	State University of New York College of Optometry	New York	New York	United States	10036
8	The Ohio State University College of Optometry	Columbus	Ohio	United States	43210
9	Pennsylvania College of Optometry	Philadelphia	Pennsylvania	United States	19141