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Search / Trial NCT04487249

Trial of Vision Therapy for Intermittent Exotropia

Launched by SOUTHERN CALIFORNIA COLLEGE OF OPTOMETRY AT MARSHALL B. KETCHUM UNIVERSITY · Jul 22, 2020

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Intermittent Exotropia Vision Therapy

ClinConnect Summary

This clinical trial is studying the effectiveness of vision therapy for children aged 8 to 16 who have a condition called intermittent exotropia. This condition causes one eye to turn outward at a distance, which can affect how well a child sees and their overall eye coordination. The trial aims to see if vision therapy can help improve control of this eye condition compared to simply observing it without treatment. If successful, the results may lead to a larger study in the future.

To be eligible for the trial, participants must have specific eye measurements that show they have intermittent exotropia and must not have received certain treatments for this condition in the last few months. Participants will be randomly assigned to either receive vision therapy or be monitored without treatment. Families can expect regular check-ups and assessments throughout the trial to see how well the therapy is working. It's important to note that this trial is currently looking for participants, and those interested should be willing to commit to the study without relocating for at least six months.

Gender

ALL

Eligibility criteria

  • Major Inclusion Criteria-
  • Age 8 - 16 years
  • * Intermittent exotropia meeting all of the following:
  • Distance exodeviation of 15∆ to 35∆ by prism alternating cover test (PACT)
  • IXT, exophoria, or orthophoria at near
  • Near exodeviation that does not exceed the distance exodeviation by more than 10∆
  • Mean distance control score of 2 points or more with at least one measure being 3 points or higher
  • Mean near control score less than 5 points
  • 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-
  • Treatment for IXT or amblyopia (other than refractive correction) within 3 months prior to enrollment
  • Office-based vision therapy for IXT within 6 months prior to enrollment
  • Prior office-based vision therapy for IXT of ≥10 sessions
  • Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)

About Southern California College Of Optometry At Marshall B. Ketchum University

The Southern California College of Optometry at Marshall B. Ketchum University is a leading institution committed to advancing optometric education, research, and clinical care. With a focus on innovative practices and evidence-based approaches, the college fosters a collaborative environment that integrates academic rigor with hands-on experience. The institution actively engages in clinical trials aimed at improving vision health and enhancing patient outcomes, leveraging its state-of-the-art facilities and expert faculty to contribute to the broader field of optometry. Through its commitment to excellence and community service, the college plays a pivotal role in shaping the future of eye care.

Locations

Columbus, Ohio, United States

Stanford, California, United States

Memphis, Tennessee, United States

Birmingham, Alabama, United States

Philadelphia, Pennsylvania, United States

Fullerton, California, United States

Patients applied

0 patients applied

Trial Officials

Angela Chen, OD, MS

Study Chair

Southern California College of Optometry at Marshall B. Ketchum University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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