N/A
N=197
Bilateral Lateral Rectus Recession Versus Unilateral Recess-Resect for Intermittent Exotropia
Exotropia
Bottom Line
View on ClinicalTrials.gov: NCT01032603 ↗Enrolled (actual)
197
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Number of Participants With Suboptimal Surgical Outcome as Assessed by Motor Alignment and Stereoacuity at Near by 3 Years — 43; 33 Participants — p=0.24
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bilateral lateral rectus recession (BLRc) (Procedure); Unilateral lateral rectus recession with medial rectus resection (R&R) (Procedure)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Jaeb Center for Health Research
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Suboptimal Surgical Outcome as Assessed by Motor Alignment and Stereoacuity at Near by 3 Years |
43; 33 | 0.24 |
| SECONDARY Patients With Exotropia by 3 Years |
31; 22 | 0.25 |
| SECONDARY Patients With Constant Esotropia by 3 Years |
3; 9 | 0.06 |
| SECONDARY Number of Participants With Stereo Loss by 3 Years |
13; 9 | 0.36 |
| SECONDARY Number of Participants With Exotropia Control at Distance at 3 Years |
19; 25; 25; 22; 14; 11 | — |
| SECONDARY Mean Distance Control at 3 Years |
1.2; 1.0 | 0.44 |
| SECONDARY Change in Distance Exotropia Control at 3 Years |
2.3; 2.5 | — |
| SECONDARY Number of Participants With Exotropia Control at Near at 3 Years |
20; 21; 36; 32; 16; 13 | — |
| SECONDARY Mean Near Control at 3 Years |
0.7; 0.6 | 0.64 |
| SECONDARY Change in Near Exotropia Control at 3 Years |
1.3; 1.1 | — |
| SECONDARY Number of Participants With Distance PACT at 3 Years |
10; 21; 23; 17; 15; 12 | — |
| SECONDARY Mean Distance PACT at 3 Years |
10; 9 | 0.21 |
| SECONDARY Change in Distance PACT From Baseline to 3 Years |
16; 18 | — |
| SECONDARY Number of Participants With Near PACT at 3 Years |
11; 15; 21; 24; 16; 9 | — |
| SECONDARY Mean Near PACT at 3 Years |
10; 9 | 0.38 |
| SECONDARY Change in Near PACT From Baseline to 3 Years |
15; 16 | — |
| SECONDARY Participants With Near Stereoacuity Measures at 3 Years |
34; 37; 23; 17; 19; 12 | — |
| SECONDARY Mean Near Stereoacuity at 3 Years |
1.9; 1.8 | 0.93 |
| SECONDARY Change in Near Stereoacuity From Baseline to 3 Years |
0.2; 0.2 | — |
| SECONDARY Participants Distance Stereoacuity at 3 Years |
30; 35; 17; 7; 20; 14 | — |
| SECONDARY Mean Distance Stereoacuity at 3 Years |
2.2; 2.2 | 0.82 |
| SECONDARY Change in Distance Stereoacuity From Baseline to 3 Years |
0.1; 0.1 | — |
| SECONDARY Health Related Quality of Life |
91; 86; 82; 82; 86; 91 | 0.30 |
| SECONDARY Cumulative Number of Patients With Reoperation by 3 Years |
9; 4 | — |
| SECONDARY Number of Participants With Complete or Near-Complete Resolution at 3 Years |
26; 35 | — |
| SECONDARY Participants Suboptimal Surgical Outcome at 3 Years |
25; 13 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 3 to 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 requiring surgery are allowed
- Limitation of ocular rotations due to restrictive or paretic strabismus
- Craniofacial malformations affecting the orbits
- Interocular visual acuity difference of more than 0.2 logMAR (2 lines on ATS HOTV for patients 3 to 6:1 by gradient method)
- Prior strabismus surgery or botulinum toxin injection
- Ocular disorders that would reduce visual acuity (except refractive error)
- Prior intraocular or refractive surgery
- Significant neurological impairment such as cerebral palsy. Patients with mild speech and/or learning disabilities are eligible.
- Investigator planning to change refractive correction at this time (if the patient is otherwise eligible, the investigator should consider prescribing refractive correction and bringing the patient back at a later time for enrollment).
Data sourced from ClinicalTrials.gov (NCT01032603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.