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

Strabismus Clinical Trial

Official title:

A Randomized Comparison of Bilateral Recession With Unilateral Recession-Resection as Surgery for Infantile Esotropia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304577
• Other study ID #: 662720
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2006
• Last updated: March 17, 2006
• Start date: January 1998
• Est. completion date: December 2001

Study information

• Verified date: September 2005
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 8 Years

Eligibility

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°

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Esotropia
• Strabismus

Intervention

Procedure:
• Bilateral recession

• Unilateral recession and resection

Locations

Country	Name	City	State
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
Netherlands	Dept. Ophthalmology	Maastricht
Netherlands	Erasmus MC	Rotterdam
Netherlands	Dept. Ophthalmology	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Countries where clinical trial is conducted

Germany,  Netherlands,