N/A
N=60
Augmented Medial Rectus Muscle Recession Versus Posterior Scleral Fixation in Partially Accommodative Esotropia
Partially Accommodative Esotropia
Bottom Line
View on ClinicalTrials.gov: NCT02413463 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Success Rate — 12; 18 Participants — p=0.18
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- augmented recession (Procedure); Faden (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Cairo University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate |
12; 18 | 0.18 |
| SECONDARY Angle of Deviation With Spectacles for Both Distance and Near |
-1; -3; 2; -1 | 0.22 |
| SECONDARY Angle of Deviation Without Spectacles for Both Distance and Near |
2; -1; 14; 6 | 0.02 sig |
| SECONDARY Angle Disparity |
15; 10 | 0.03 sig |
| SECONDARY Surgery Time |
28; 51 | <0.01 sig |
| SECONDARY Number of Patients Who Developed Intraoperative and/or Postoperative Complications |
0; 0 | — |
Summary
Prospective randomized interventional comparative study
Eligibility Criteria
Inclusion Criteria
- Acquired residual esotropia greater than 14 PD at distance fixation that exists despite full correction of hypermetropic refractive error with the angle of deviation for near not exceeding that of distance by more than 15 PD
- Lack of previous extra ocular muscle surgery
Exclusion Criteria
- Fully accommodative esotropia, partially accommodative esotropia with convergence excess, non-accommodative esotropia or infantile esotropia
- The presence of neurologic, developmental or ocular structural disorders
- History of previous eye surgery
- Patients requiring simultaneous oblique muscles surgery
- Follow up less than 6 months
Data sourced from ClinicalTrials.gov (NCT02413463). 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.