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Vision Therapy for Intermittent Exotropia (VT-IXT Trial)
N/A
Recruiting
Research Sponsored by Southern California College of Optometry at Marshall B. Ketchum University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 8 - 16 years
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether vision therapy can help control a type of eye misalignment. The results will help determine whether to do a longer trial testing the therapy.
Who is the study for?
This trial is for kids aged 8-16 with a specific eye alignment issue called intermittent exotropia, where one eye occasionally drifts outward. They should have certain levels of control over their eye movement and good depth perception. Kids who plan to move soon or can't commit to the study's process are not eligible.
What is being tested?
The study tests if vision therapy can help manage intermittent exotropia better than just watching the condition without treatment. Participants will be randomly assigned to either receive vision therapy or be observed, helping decide if more extensive research is needed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 8 and 16 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Distance Control Score
Secondary study objectives
Change in Distance Control
No Spontaneous Tropia
Other study objectives
Change in Vergence and Accommodative Measures
Objective Eye Movement Recordings
Suppression Status
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Vision TherapyExperimental Treatment1 Intervention
Participants will receive 20 consecutive weeks of office-based vision therapy with home therapy.
Group II: ObservationActive Control1 Intervention
Participants will receive no treatment for IXT is received during the study unless one of the deterioration criteria is met.
Find a Location
Who is running the clinical trial?
Southern College of OptometryOTHER
6 Previous Clinical Trials
294 Total Patients Enrolled
Case Western Reserve UniversityOTHER
309 Previous Clinical Trials
251,201 Total Patients Enrolled
Salus UniversityOTHER
14 Previous Clinical Trials
919 Total Patients Enrolled
2 Trials studying Intermittent Exotropia
100 Patients Enrolled for Intermittent Exotropia
American Academy of OptometryOTHER
5 Previous Clinical Trials
235 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,656 Previous Clinical Trials
2,444,315 Total Patients Enrolled
Southern California College of Optometry at Marshall B. Ketchum UniversityLead Sponsor
23 Previous Clinical Trials
1,399 Total Patients Enrolled
Stanford UniversityOTHER
2,491 Previous Clinical Trials
17,519,011 Total Patients Enrolled
Ohio State UniversityOTHER
871 Previous Clinical Trials
655,674 Total Patients Enrolled
Angela Chen, OD, MSStudy ChairSouthern California College of Optometry at Marshall B. Ketchum University