Status:
COMPLETED
Bilateral Recession or Unilateral Recession-Resection as Surgery for Infantile Esotropia
Lead Sponsor:
Erasmus Medical Center
Conditions:
Strabismus
Eligibility:
All Genders
3-8 years
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 muscl...
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...
Eligibility Criteria
Inclusion
- 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
- 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°
Key Trial Info
Start Date :
January 1 1998
Trial Type :
OBSERVATIONAL
End Date :
December 1 2001
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00304577
Start Date
January 1 1998
End Date
December 1 2001
Last Update
March 20 2006
Active Locations (12)
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1
Dept. Ophthalmology
Bonn, Germany
2
Dept. Ophthalmology
Erlangen, Germany
3
Dept. Ophthalmology
Essen, Germany
4
Dept. Ophthalmology
Frankfurt, Germany