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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Ohio State University | OTHER |
| Salus University | OTHER |
| University of Alabama at Birmingham |
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The main objective of this randomized trial comparing vision therapy to observation is to determine the short-term effectiveness of vision therapy on distance intermittent exotropia control. The results will help determine whether to proceed to a full-scale, long-term randomized trial.
Vision therapy (VT) is a commonly prescribed treatment for children with intermittent exotropia (IXT). The effectiveness of VT as a treatment modality for children with IXT is unknown because previous studies have largely limited observational or retrospective case series without comparison groups. The objective of this multi-centered pilot randomized trial of VT for IXT compared to observation is to 1) determine the short-term effectiveness of VT on distance intermittent exotropia and 2) determine the feasibility of recruitment and retention of children aged 8 to 16 years old with IXT to participate in a randomized trial of 20 weeks of in-office VT. The results of this trial will provide the needed information to plan and conduct a large-scale randomized trial to determine short-term and long-term effectiveness of VT for IXT in children, with the full-scale randomized trial helping to fill in the gaps in scientific knowledge concerning VT as a treatment for IXT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vision Therapy | Experimental | Participants will receive 20 consecutive weeks of office-based vision therapy with home therapy. |
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| Observation | No Intervention | Participants will receive no treatment for IXT is received during the study unless one of the deterioration criteria is met. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vision Therapy | Other | 20 consecutive weeks of office-based vision therapy with home therapy that aim to improve the participant's vergence skills, accommodative skills, and sensory fusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Distance Control Score | The primary analysis will be an intent-to-treat comparison of mean distance control score, determine by the intermittent exotropia office control scale, at outcome using an analysis of covariance model, which will adjust for baseline distance control. The intermittent exotropia office control scale grades the control on a scale of 0 (best control; phoria) to 5 (worst control; constant exotropia). | 21 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| No Spontaneous Tropia | The proportion of participants with no spontaneous tropia at outcome will be compared between treatment groups.No spontaneous tropia is defined as control score of 2 or less on all three assessments of control at distance and near and no exotropia lasting more than 5 seconds throughout the examination. | 21 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vergence and Accommodative Measures | The near point of convergence, positive and negative fusional vergence ranges at distance and near, vergence facility, accommodative amplitude, and accommodative facility at outcome will be compared between treatment groups adjusting for the corresponding baseline value. The analysis will be completed separately for each vergence and accommodative measures. | 21 weeks |
Major Inclusion Criteria-
Age 8 - 16 years
Intermittent exotropia meeting all of the following:
Random dot stereopsis of 200" or better on Preschool Randot Stereotest
Willingness to accept randomization and no plan to relocate in the next 6 months
Major Exclusion Criteria-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Chen, OD, MS | Contact | 714-463-7569 | angelachen@ketchum.edu |
| Name | Affiliation | Role |
|---|---|---|
| Angela Chen, OD, MS | Southern California College of Optometry at Marshall B. Ketchum University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama in Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D009988 | Orthoptics |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| OTHER |
| Southern College of Optometry | OTHER |
| Case Western Reserve University | OTHER |
| American Academy of Optometry | OTHER |
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| Change in Distance Control |
The proportion of participants with >= 1 point change in control and >= 2 points change in control will be compared between treatment groups. |
| 21 weeks |
| Suppression Status | Suppression status will be compared at outcome between treatment groups, adjusting for baseline suppression status. Suppression status when the participant's eyes are in tropic position will be assessed using the suppression scale ranging from 0 (negligible suppression) to 4 (dense suppression). | 21 weeks |
| Objective Eye Movement Recordings | Frequency of intermittent exotropia by objective eye movement recordings will be compared between treatment groups. | 21 weeks |
| Southern California College of Optometry at Marshall B. Ketchum University | Recruiting | Fullerton | California | 92831 | United States |
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| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| Salus University | Recruiting | Philadelphia | Pennsylvania | 19141 | United States |
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| Southern College of Optometry | Recruiting | Memphis | Tennessee | 38104 | United States |
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