CompletedNot Applicable

Bilateral Lateral Rectus Recession Versus Unilateral Recess-Resect for Intermittent Exotropia

United States197 participantsStarted 2010-06-01

Plain-language summary

The purpose of this study is to evaluate the effectiveness of bilateral lateral rectus muscle recession versus unilateral lateral rectus recession with medial rectus resection procedures for the treatment of basic type and pseudo divergence excess type intermittent exotropia.

Who can participate

Age range

3 Years – 10 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: * Age 3 to \< 11 years * Intermittent exotropia (manifest deviation) meeting all of the following: * Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near * Largest exodeviation at either distance, near OR remote distance between 15 and 50 prism diopters (PD) (inclusive) by prism and alternate cover test (PACT) * Exodeviation at least 15 PD at distance and near by PACT * Basic type or pseudo divergence excess type * Stereoacuity of 400 arcsec or better at near by Preschool Randot stereotest (better of 2 measures) * Visual acuity in the worse eye at least 0.3 logMAR (20/40 on ATS HOTV or 70 letters on E-ETDRS) * No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV or 10 letters on E-ETDRS testing) * Absence of high AC/A ratio (exclude \> 6:1) * No previous intraocular surgery, strabismus surgery, or botulinum toxin treatment * Investigator planning to perform surgery for correction of IXT * No hyperopia greater than +3.50 D spherical equivalent (SE) in either eye Exclusion Criteria: * Coexisting vertical deviation, oblique muscle dysfunction, dissociated vertical deviation (DVD), or A or V pattern, any of which the investigator plans to address with vertical transposition of horizontal rectus muscles, oblique surgery, or vertical rectus muscle surgery, i.e., only small vertical deviations, oblique muscle dysfunction, DVD, and A or V patterns not…

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

Number of Participants With Suboptimal Surgical Outcome as Assessed by Motor Alignment and Stereoacuity at Near by 3 Years

Timeframe: 3 years

Trial details

NCT IDNCT01032603

SponsorJaeb Center for Health Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02-09

Results submitted2019-03-01

View on ClinicalTrials.gov More Exotropia trials

Who can participate

Age range

3 Years – 10 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.