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The goal of this randomized controlled trial is to test the effectiveness of non-invasive brain stimulation in treating adults with symptomatic convergence insufficiency compared to vergence/accommodative therapy. The main questions it aims to answer are:
The investigators hypothesize that non-invasive brain stimulation will shorten the treatment time from 12 weeks to 8 weeks of office-based vergence/accommodative therapy and that non-invasive brain stimulation alone would be equally effective as office-based vergence/accommodative therapy in improving symptomatic convergence insufficiency.
Participants will be randomized into one of three treatment groups:
Researchers will compare baseline measurements of near point of convergence (NPC) and positive fusional vergence (PFV) to post-treatment measurements for each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIBS-OBVAT | Active Comparator | 8 sessions of non-invasive brain stimulation with 8 weeks of office-based vergence/accommodative therapy. |
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| NIBS | Active Comparator | 8 sessions of non-invasive brain stimulation only. |
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| OBVAT | Sham Comparator | 8 sessions of sham stimulation with 8 weeks of office-based vergence/accommodative therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anodal-Transcranial Direct Current Stimulation | Device | Non-invasive brain stimulation will involve the use of anodal transcranial direct current stimulation to apply a 2 milliamp current over the left frontal eye field for approximately 20 minutes with a ramp up to the maximum programmed current and ramp down of 20 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| Near Point of Convergence (NPC) | A change in the NPC break and recovery values measured in centimeters (cm) from baseline after treatment. | 4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment |
| Positive Fusional Vergence (PFV) | A change in the near PFV blur, break, and recovery values measured in prism diopters (∆) from baseline after treatment. | 4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Convergence Insufficiency Symptoms Survey (CISS) | A change in the CISS score from baseline after treatment. The minimum score is 0 and the maximum score is 60. Lower scores indicate a better outcome. | 8 weeks during treatment; 6 months and 12 months post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arijit Chakraborty, PhD | Contact | 630-960-3172 | achakr@midwestern.edu | |
| Adrienne C Quan, OD | Contact | 630-960-3183 | aquan@midwestern.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwestern University Eye Institute | Recruiting | Downers Grove | Illinois | 60515 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33263359 | Background | 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. | |
| 33186192 | Background | Alvarez TL, Scheiman M, Santos EM, Yaramothu C, d'Antonio-Bertagnolli JV. Convergence Insufficiency Neuro-mechanism in Adult Population Study Randomized Clinical Trial: Clinical Outcome Results. Optom Vis Sci. 2020 Dec;97(12):1061-1069. doi: 10.1097/OPX.0000000000001606. |
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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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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Office-Based Vergence/Accommodative Therapy | Behavioral | Office-based vergence accommodative therapy involves weekly in-office appointments with the therapist lasting approximately 60 minutes per visit during which time in-office procedures will be performed, and home therapy procedures will be demonstrated. Participants will be prescribed 15 minutes of home reinforcement therapy procedures to be completed 5 days per week. Therapy will consist of two phases adapted from the Convergence Insufficiency Treatment Trial (CITT). Therapy procedures will include gross convergence, accommodation. non-computer based vergence, and computer-based vergence. |
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| Sham Transcranial Direct Current Stimulation | Device | Sham transcranial direct current stimulation will be applied over the left frontal eye field with the current ramping up for 20 seconds before ramping down for 20 seconds. The 2 milliamp current stimulation will occur for only a few seconds at the start and at the end of the 20 minutes. |
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| 18852411 | Background | Convergence Insufficiency Treatment Trial Study Group. Randomized clinical trial of treatments for symptomatic convergence insufficiency in children. Arch Ophthalmol. 2008 Oct;126(10):1336-49. doi: 10.1001/archopht.126.10.1336. |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |