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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21EY13164-1 | |||
| 1R21EY013164 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
The Convergence Insufficiency Treatment Trial (CITT) is a multi-center, placebo-controlled, single-masked, clinical trial designed to compare the benefits of two commonly used treatment approaches for patients with convergence insufficiency (CI)
Considerable controversy exists regarding the best treatment for convergence insufficiency (CI), a common condition that often interferes with the ability to perform near work. The two most widely used treatments have significant differences in costs and in practitioner perceived utility. Pencil push-up therapy (PPT) is a simple, low-cost treatment in which patients are prescribed a single procedure to perform at home with only periodic follow-up. Office-based vision therapy (OBVT) is a more comprehensive, time-consuming, complex, and costly treatment in which patients are scheduled for weekly in-office therapy visits and are often prescribed a specific sequence of therapeutic procedures to perform at home. It is important to consider whether either, neither, or both treatments are effective.
The Convergence Insufficiency Treatment Trial (CITT) is a prospective, masked-examiner, multi-center clinical trial in which patients are randomized to one of these two treatment approaches. The primary goal is to answer the following question:
After 12 weeks of treatment, is one therapy more effective than the other in improving CI signs and symptoms? We will test the null hypothesis that there is no difference in the distribution of outcomes between the two populations.
The primary outcome measure will be a classification of each patient as a "success," "improvement," or "failure." This classification will be based on the level of improvement in both the signs (near point of convergence and positive fusional vergence) and symptoms of CI.
Additional questions relate to longer term effects:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pencil Push-ups | Procedure | |||
| Office-based Vision Therapy | Procedure | |||
| Placebo Office-based Vision Therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey |
| Measure | Description | Time Frame |
|---|---|---|
| Near Point of Convergence | ||
| Positive Fusional Vergence at Near |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Scheiman, OD | Pennsylvania College of Optometry | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California College of Optometry | Fullerton | California | 92831 | United States | ||
| State University of New York, College of Optometry |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14688547 | Background | Borsting EJ, Rouse MW, Mitchell GL, Scheiman M, Cotter SA, Cooper J, Kulp MT, London R; Convergence Insufficiency Treatment Trial Group. Validity and reliability of the revised convergence insufficiency symptom survey in children aged 9 to 18 years. Optom Vis Sci. 2003 Dec;80(12):832-8. doi: 10.1097/00006324-200312000-00014. | |
| 11999152 | Background | Gallaway M, Scheiman M, Malhotra K. The effectiveness of pencil pushups treatment for convergence insufficiency: a pilot study. Optom Vis Sci. 2002 Apr;79(4):265-7. doi: 10.1097/00006324-200204000-00013. |
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| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
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| New York |
| New York |
| 10036 |
| United States |
| The Ohio State University, Optometry Coordinating Center | Columbus | Ohio | 43210 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Pacific University College of Optometry | Forest Grove | Oregon | 97116 | United States |
| Eye Institute, Pennsylvania College of Optometry | Philadelphia | Pennsylvania | 19141 | United States |
| University of Houston, College of Optometry | Houston | Texas | 77204 | United States |
| 11913841 | Background | Scheiman M, Cooper J, Mitchell GL, de LP, Cotter S, Borsting E, London R, Rouse M. A survey of treatment modalities for convergence insufficiency. Optom Vis Sci. 2002 Mar;79(3):151-7. doi: 10.1097/00006324-200203000-00009. |
| 15642806 | Result | Scheiman M, Mitchell GL, Cotter S, Cooper J, Kulp M, Rouse M, Borsting E, London R, Wensveen J; Convergence Insufficiency Treatment Trial Study Group. A randomized clinical trial of treatments for convergence insufficiency in children. Arch Ophthalmol. 2005 Jan;123(1):14-24. doi: 10.1001/archopht.123.1.14. |
| 16044063 | Result | Scheiman M, Mitchell GL, Cotter S, Kulp MT, Cooper J, Rouse M, Borsting E, London R, Wensveen J. A randomized clinical trial of vision therapy/orthoptics versus pencil pushups for the treatment of convergence insufficiency in young adults. Optom Vis Sci. 2005 Jul;82(7):583-95. doi: 10.1097/01.opx.0000171331.36871.2f. |
| 33263359 | Derived | Scheiman M, Kulp MT, Cotter SA, Lawrenson JG, Wang L, Li T. Interventions for convergence insufficiency: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 2;12(12):CD006768. doi: 10.1002/14651858.CD006768.pub3. |