Convergence Insufficiency Treatment Trial (CITT)

Status Active, not recruiting

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.

Clinical Trial 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

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00338611
Study type	Interventional
Source	National Eye Institute (NEI)
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	July 2005
Completion date	September 2009

View Details

See also
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Terminated	`NCT03123822` - Spectacles Lens in Concussed Kids	N/A
Completed	`NCT00472407` - Screening for Convergence Insufficiency in School-age Children
Completed	`NCT00347945` - Randomized Trial of Treatments for Convergence Insufficiency	Phase 3
Completed	`NCT05070767` - Neurolens Headache Study	N/A
Completed	`NCT03319966` - Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
Recruiting	`NCT04691427` - Effectiveness of Virtual Reality Vision Therapy - VERVE	Early Phase 1
Terminated	`NCT05087563` - Neurolens Convergence Insufficiency Study	N/A
Completed	`NCT02607384` - The Baltimore Reading and Eye Disease Study	N/A
Active, not recruiting	`NCT02207517` - Office-based Vision Therapy for Improving Reading and Attention in Children With Convergence Insufficiency	Phase 3
Completed	`NCT00347581` - A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children	Phase 3
Recruiting	`NCT05603962` - The Effectiveness of Visual Training in Convergence Insufficiency Patients	N/A
Completed	`NCT01515943` - Convergence Insufficiency Treatment Study (CITS)	N/A
Recruiting	`NCT05877560` - Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency	N/A
Recruiting	`NCT05948046` - The Health-Related Quality of Life of the Patients With Symptomatic Convergence Insufficiency
Recruiting	`NCT05012384` - Effect of Vergence Exercises for Patients With Convergence Insufficiency After Concussion.	N/A
Recruiting	`NCT05761106` - Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders	N/A
Completed	`NCT02510040` - A Prospective Observational Study of Adult Strabismus
Recruiting	`NCT05311917` - Home Vision Therapy and Prism Prescription in Presbyopic Persons With Convergence Insufficiency	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.