Bilateral Recession or Unilateral Recession-Resection as Surgery for Infantile Esotropia

This study has been completed.
Sponsor:
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00304577
First received: March 17, 2006
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Strabismus
Procedure: Bilateral recession
Procedure: Unilateral recession and resection
Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: A Randomized Comparison of Bilateral Recession With Unilateral Recession-Resection as Surgery for Infantile Esotropia

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Study Start Date: January 1998
Estimated Study Completion Date: December 2001
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.

  Eligibility

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible were all children aged three to eight years with a normal psychophysical development, and onset of esotropia before age one who visited one of the clinics during the study period.

Exclusion Criteria:

  • previous strabismus surgery, an angle of strabismus larger than 24° or smaller than 10°, any normal binocular vision, convergence excess with angle of strabismus at near fixation 1.5 times larger than the angle at distance, more than 1 line Logmar acuity difference between the two eyes, hypermetropia over 6 diopters or myopia over 3 diopters, up- or downshoot in (25°) adduction more than 8°, V-pattern (25° up and down gaze) over 8°, A-pattern (25° up and down gaze) over 5° and manifest vertical strabismus over 4°
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304577

Locations
Germany
Dept. Ophthalmology
Bonn, Germany
Dept. Ophthalmology
Erlangen, Germany
Dept. Ophthalmology
Essen, Germany
Dept. Ophthalmology
Frankfurt, Germany
Dept. Ophthalmology
Freiburg, Germany
Dept. Ophthalmology
Hamburg, Germany
Dept. Ophthalmology
Heidelberg, Germany
Dept. Ophthalmology
Regensburg, Germany
Dept. Ophthalmology
Tuebingen, Germany
Netherlands
Dept. Ophthalmology
Maastricht, Netherlands
Erasmus MC
Rotterdam, Netherlands, 3015 GD
Dept. Ophthalmology
Utrecht, Netherlands
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Study Chair: Huib J. Simonsz, MD, PhD Erasmus MC, Rotterdam
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00304577     History of Changes
Other Study ID Numbers: 662720
Study First Received: March 17, 2006
Last Updated: March 17, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
Strabismus
Esotropia
Surgical techniques

Additional relevant MeSH terms:
Esotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014