Trials / Completed
CompletedNCT00304577
Bilateral Recession or Unilateral Recession-Resection as Surgery for Infantile Esotropia
A Randomized Comparison of Bilateral Recession With Unilateral Recession-Resection as Surgery for Infantile Esotropia
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- —
- Sponsor
- Erasmus Medical Center · Academic / Other
- Sex
- All
- Age
- 3 Years – 8 Years
- Healthy volunteers
- Accepted
Summary
Infantile esotropia is corrected in most cases by bilateral recession of the medial rectus muscles (BR) or by unilateral recession of the medial rectus muscle and resection of the lateral rectus muscle (RR). We compared the outcome of these techniques in a randomized prospective study.
Detailed description
We randomly assigned 124 patients (average age 5.8) from twelve participating clinics in Germany and the Netherlands to either BR or RR. Patients did not have demonstrable binocular vision at baseline. The angle of strabismus was measured pre- and postoperatively in a standardized fashion. The primary parameter to assess difference between BR and RR was the variation of the latent angle of strabismus at distance at three months postoperatively, secondary outcomes were reduction of convergence excess and binocular vision.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Bilateral recession | |
| PROCEDURE | Unilateral recession and resection |
Timeline
- Start date
- 1998-01-01
- Completion
- 2001-12-01
- First posted
- 2006-03-20
- Last updated
- 2006-03-20
Locations
12 sites across 2 countries: Germany, Netherlands
Source: ClinicalTrials.gov record NCT00304577. Inclusion in this directory is not an endorsement.