Clinical Trial: Bilateral Recession or Unilateral Recession-Resection as Surgery for Infantile Esotropia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Randomized Comparison of Bilateral Recession With Unilateral Recession-Resection as Surgery for Infantile Esotropia

Brief 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 Summary: 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.
Sponsor: Erasmus Medical Center

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Erasmus Medical Center

Dates:
Date Received: March 17, 2006
Date Started: January 1998
Date Completion: December 2001
Last Updated: March 17, 2006
Last Verified: September 2005