TerminatedNot Applicable

Evaluation of Exotropia After Patching the Eye or After Prism Adaptation

Stopped: lack of ability to enroll from other sites

United States, Canada, India1 participantsStarted 2024-08-27

Plain-language summary

This study intends to determine the number and percent of subjects initially diagnosed with divergence excess exotropia which would be reclassified as simulated divergence excess exotropia if tested after 24 hours of monocular occlusion (patching) or after prism adaptation for the distance angle.

Who can participate

Age range

17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosed with divergence excess exotropia according to standard criteria (see Study Procedures for specifics) * No prior strabismus surgery * Able to cooperate with testing (by examiner determination) * Neurologically normal except for strabismus (ADHD and autism spectrum are not exclusion criteria as long as the subject can cooperate for necessary testing) * Not amblyopic at the time of enrollment (best-corrected visual acuity in both eyes of 20/40 or better) * Under 18 years of age. There is no lower age limit as long as the subject can cooperate for the required testing. * No diagnosis of dissociated vertical deviation Exclusion Criteria: * No diagnosis of divergence excess exotropia according to standard criteria (see Study Procedures for specifics) * Prior strabismus surgery * Unable to cooperate with testing (by examiner determination) * Diagnosed with a neurological disorder (ADHD and autism spectrum are not exclusion criteria as long as the subject can cooperate for necessary testing) * Best-corrected visual acuity in either eye worse than 20/40 * 18 years of age or older * Diagnosed with dissociated vertical deviation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent of participants reclassified as divergence excess exotropia

Timeframe: 2 weeks

Percent of participants reclassified as simulated divergence excess exotropia

Timeframe: 2 weeks

Trial details

NCT IDNCT05242510

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-18

View on ClinicalTrials.gov More Exotropia trials

Who can participate

Age range

17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.