Bilateral Lateral Rectus Recession Versus Unilateral Recess-Resect for Intermittent Exotropia (NCT01032603) | Clinical Trial Compass
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 range3 Years – 10 Years
SexALL
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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…
What they're measuring
1
Number of Participants With Suboptimal Surgical Outcome as Assessed by Motor Alignment and Stereoacuity at Near by 3 Years