Bilateral Recession or Unilateral Recession-Resection as Surgery for Infantile Esotropia - Full Text View

Sponsored by:	Erasmus Medical Center
Information provided by:	Erasmus Medical Center
ClinicalTrials.gov Identifier:	NCT00304577

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 III

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

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

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
Essen, Germany
Dept. Ophthalmology
Freiburg, Germany
Dept. Ophthalmology
Heidelberg, Germany
Dept. Ophthalmology
Bonn, Germany
Dept. Ophthalmology
Regensburg, Germany
Dept. Ophthalmology
Hamburg, Germany
Dept. Ophthalmology
Tuebingen, Germany
Dept. Ophthalmology
Frankfurt, Germany
Dept. Ophthalmology
Erlangen, Germany
Netherlands
Erasmus MC
Rotterdam, Netherlands, 3015 GD
Dept. Ophthalmology
Maastricht, Netherlands
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

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

Keywords provided by Erasmus Medical Center:

Strabismus
Esotropia
Surgical techniques

Study placed in the following topic categories:

Esotropia
Ocular Motility Disorders
Eye Diseases
Strabismus
Motor Neuro-ophthalmic Disorders

Additional relevant MeSH terms:

Esotropia
Ocular Motility Disorders
Eye Diseases

Nervous System Diseases
Strabismus
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on August 24, 2009