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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00304577
Recruitment Status : Completed
First Posted : March 20, 2006
Last Update Posted : March 20, 2006
Sponsor:
Information provided by:
Erasmus Medical Center

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.

Condition or disease Intervention/treatment
Strabismus Procedure: Bilateral recession Procedure: Unilateral recession and resection

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.

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Study Type : Observational
Observational Model: Defined Population
Time Perspective: Prospective
Official Title: A Randomized Comparison of Bilateral Recession With Unilateral Recession-Resection as Surgery for Infantile Esotropia
Study Start Date : January 1998
Study Completion Date : December 2001

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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
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°

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304577


Locations
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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
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Study Chair: Huib J. Simonsz, MD, PhD Erasmus MC, Rotterdam
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ClinicalTrials.gov Identifier: NCT00304577    
Other Study ID Numbers: 662720
First Posted: March 20, 2006    Key Record Dates
Last Update Posted: March 20, 2006
Last Verified: September 2005
Keywords provided by Erasmus Medical Center:
Strabismus
Esotropia
Surgical techniques
Additional relevant MeSH terms:
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Strabismus
Esotropia
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases