Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT05877560

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

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency | DecenTrialz