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NCT05877560 | RECRUITING | Convergence Insufficiency

Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency
Sponsor:

Midwestern University

Information provided by (Responsible Party):

Arijit Chakraborty

Brief Summary:

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.

Condition or disease

Convergence Insufficiency

Intervention/treatment

Anodal-Transcranial Direct Current Stimulation

Office-Based Vergence/Accommodative Therapy

Sham Transcranial Direct Current Stimulation

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Randomized Controlled Study Using Non-invasive Brain Stimulation to Facilitate the Effectiveness of Vergence/Accommodative Therapy in Symptomatic Convergence Insufficiency
Actual Study Start Date : 2025-03-01
Estimated Primary Completion Date : 2028-12-31
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Best-corrected visual acuity of \> 20/25 in each eye at distance and near
  • * Exophoria at near at least 4∆ greater than at far
  • * Receded near point of convergence of \> 6 cm break
  • * Insufficient positive fusional vergence at near (\< 15∆ base-out blur or break)
  • * CISS score of 16 and greater for children or 21 and greater for adults
  • * Have had a dilated fundus examination within the last 12 months
  • * Informed consent and willingness to participate in the study and be randomized
Exclusion Criteria
  • * Previously treated for convergence insufficiency with home- or office-based vergence/accommodative therapy
  • * Amblyopia (\> 2-line difference in best-corrected visual acuity between the two eyes)
  • * Constant strabismus
  • * History of strabismus surgery
  • * Convergence insufficiency secondary to acquired brain injury or neurological disorder
  • * Manifest or latent nystagmus
  • * Systemic disease known to affect accommodation, vergence, and ocular motility including multiple sclerosis, Graves disease, myasthenia gravis, Parkinson's disease, cerebral palsy, and diabetes
  • * Developmental disability, attention deficit hyperactivity disorder (ADHD), learning disability or cognitive dysfunction that would interfere with treatment
  • * Taking medications that can affect normal neurological function including antipsychotics, antiepileptics, and opioids
  • * Presence of metal or electronic implants in or on the body, including pacemakers
Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

Location Details

NCT05877560

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Locations

RECRUITING

United States, Illinois

Midwestern University Eye Institute

Downers Grove, Illinois, United States, 60515