Clinical Trials Directory

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

TypeNameDescription
PROCEDUREBilateral recession
PROCEDUREUnilateral 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.