Convergence Insufficiency Treatment Trial (CITT)
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| ClinicalTrials.gov Identifier: NCT00338611 |
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Recruitment Status : Unknown
Verified October 2008 by National Eye Institute (NEI).
Recruitment status was: Active, not recruiting
First Posted : June 20, 2006
Last Update Posted : March 25, 2010
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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 |
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 Type : | Interventional (Clinical Trial) |
| 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 : | July 2005 |
| Actual Primary Completion Date : | September 2008 |
| Estimated Study Completion Date : | September 2009 |
- 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
- Behavioral: 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
- Behavioral: Office-based Vision Therapy/Orthoptics
Weekly hour-long sessions of office-based vision therapy with a trained therapist and performed at-home reinforcement exercises
- Behavioral: Placebo Office-based Vision Therapy/Orthoptics
Vision activities designed to simulate office-based therapy
- Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey [ Time Frame: 12 weeks ]
- Eyes' ability to converge when performing close work [ Time Frame: 12 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 9 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338611
| United States, Alabama | |
| University of Alabama at Birmingham School of Optometry | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Southern California College of Optometry | |
| Fullerton, California, United States, 92093 | |
| Ratner Children's Eye Center | |
| La Jolla, California, United States, 92093 | |
| United States, Florida | |
| NOVA Southeastern University College of Optometry | |
| Ft. Lauderdale, Florida, United States, 33328 | |
| Bascom Palmer Eye Institute | |
| Miami, Florida, United States, 33136 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| State University of New York College of Optometry | |
| New York, New York, United States, 10036 | |
| United States, Ohio | |
| The Ohio State University College of Optometry | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Pennsylvania College of Optometry | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Study Chair: | Mitchell Scheiman, OD | Pennsylvania College of Optometry |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mitchell Scheiman, OD, Pennsylvania College of Optometry |
| ClinicalTrials.gov Identifier: | NCT00338611 |
| Other Study ID Numbers: |
NEI-107 |
| First Posted: | June 20, 2006 Key Record Dates |
| Last Update Posted: | March 25, 2010 |
| Last Verified: | October 2008 |
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vision therapy orthoptics pencil push-up therapy |
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Vision Disorders Ocular Motility Disorders Sensation Disorders Neurologic Manifestations |
Nervous System Diseases Eye Diseases Central Nervous System Diseases Cranial Nerve Diseases |