Actively Recruiting
Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency
Led by Midwestern University · Updated on 2024-12-02
150
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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: 1. Can non-invasive brain stimulation shorten the treatment time of office-based vergence/accommodative therapy for convergence insufficiency? 2. Is non-invasive brain stimulation alone just as effective as office-based vergence/accommodative therapy in treating convergence insufficiency? 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: 1. Non-invasive brain stimulation with office-based vergence/accommodative therapy. 2. Sham stimulation with office-based vergence/accommodative therapy. 3. Non-invasive brain stimulation only. Researchers will compare baseline measurements of near point of convergence (NPC) and positive fusional vergence (PFV) to post-treatment measurements for each group.
CONDITIONS
Official Title
Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Best-corrected visual acuity better than 20/25 in each eye at distance and near
- Near exophoria at least 4 prism diopters greater than at far
- Near point of convergence break greater than 6 cm
- Positive fusional vergence at near less than 15 prism diopters base-out blur or break
- CISS score of 21 or higher for adults
- Dilated fundus examination within the last 12 months
- Willingness to provide informed consent and participate in the study and randomization
You will not qualify if you...
- Previous treatment for convergence insufficiency with home- or office-based vergence/accommodative therapy
- Amblyopia with more than 2-line difference in best-corrected visual acuity between eyes
- Constant strabismus
- History of strabismus surgery
- Convergence insufficiency due to brain injury or neurological disorder
- Manifest or latent nystagmus
- Systemic diseases affecting eye muscles or movement such as multiple sclerosis, Graves disease, myasthenia gravis, Parkinson's disease, cerebral palsy, or diabetes
- Developmental disabilities, ADHD, learning disabilities, or cognitive dysfunction interfering with treatment
- Taking medications that affect neurological function including antipsychotics, antiepileptics, and opioids
- Presence of metal or electronic implants in or on the body, including pacemakers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Midwestern University Eye Institute
Downers Grove, Illinois, United States, 60515
Actively Recruiting
Research Team
A
Arijit Chakraborty, PhD
CONTACT
A
Adrienne C Quan, OD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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