NCT00304577

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 1998

Longer than P75 for all trials

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2006

Completed
Last Updated

March 20, 2006

Status Verified

September 1, 2005

First QC Date

March 17, 2006

Last Update Submit

March 17, 2006

Conditions

Strabismus

Keywords

StrabismusEsotropiaSurgical techniques

Interventions

Bilateral recessionPROCEDURE
Unilateral recession and resectionPROCEDURE

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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°

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Dept. Ophthalmology

Bonn, Germany

Location

Dept. Ophthalmology

Erlangen, Germany

Location

Dept. Ophthalmology

Essen, Germany

Location

Dept. Ophthalmology

Frankfurt, Germany

Location

Dept. Ophthalmology

Freiburg im Breisgau, Germany

Location

Dept. Ophthalmology

Hamburg, Germany

Location

Dept. Ophthalmology

Heidelberg, Germany

Location

Dept. Ophthalmology

Regensburg, Germany

Location

Dept. Ophthalmology

Tübingen, Germany

Location

Dept. Ophthalmology

Maastricht, Netherlands

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

Dept. Ophthalmology

Utrecht, Netherlands

Location

MeSH Terms

Conditions

StrabismusEsotropia

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Huib J. Simonsz, MD, PhD

    Erasmus MC, Rotterdam

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2006

First Posted

March 20, 2006

Study Start

January 1, 1998

Study Completion

December 1, 2001

Last Updated

March 20, 2006

Record last verified: 2005-09

Locations

DE(9)NL(3)