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

NCT ID: NCT00304577

Last Updated: 2006-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

1998-01-31

Study Completion Date

2001-12-31

Brief Summary

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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

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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

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Strabismus

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Bilateral recession

Intervention Type PROCEDURE

Unilateral recession and resection

Intervention Type PROCEDURE

Eligibility Criteria

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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°
Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Huib J. Simonsz, MD, PhD

Role: STUDY_CHAIR

Erasmus MC, Rotterdam

Locations

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Dept. Ophthalmology

Bonn, , Germany

Site Status

Dept. Ophthalmology

Erlangen, , Germany

Site Status

Dept. Ophthalmology

Essen, , Germany

Site Status

Dept. Ophthalmology

Frankfurt, , Germany

Site Status

Dept. Ophthalmology

Freiburg im Breisgau, , Germany

Site Status

Dept. Ophthalmology

Hamburg, , Germany

Site Status

Dept. Ophthalmology

Heidelberg, , Germany

Site Status

Dept. Ophthalmology

Regensburg, , Germany

Site Status

Dept. Ophthalmology

Tübingen, , Germany

Site Status

Dept. Ophthalmology

Maastricht, , Netherlands

Site Status

Erasmus MC

Rotterdam, , Netherlands

Site Status

Dept. Ophthalmology

Utrecht, , Netherlands

Site Status

Countries

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Germany Netherlands

Other Identifiers

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662720

Identifier Type: -

Identifier Source: org_study_id