Bilateral recession or unilateral recession-resection as surgery for infantile esotropia

ISRCTN ISRCTN72461159
DOI https://doi.org/10.1186/ISRCTN72461159
Secondary identifying numbers NTR333
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
28/01/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof H J Simonsz
Scientific

Erasmus Medical Centre Rotterdam
Department of Ophthalmology
Room Ba 104
P.O. Box 2040
Rotterdam
3015 GD
Netherlands

Email simonsz@compuserve.com

Study information

Study designMulticentre randomised single-blind active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA randomised comparison of bilateral recession with unilateral recession-resection as surgery for infantile esotropia
Study acronymBR vs RR
Study objectivesInfantile 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). The preference of BR or RR is subject of discussion and none of the many arguments have been validated. We compared the outcome of these techniques in a study.
Ethics approval(s)Received from the local ethics committee
Health condition(s) or problem(s) studiedInfantile esotropia
InterventionBilateral recession of the medial rectus muscles (BR) and unilateral recession of the medial rectus muscle and resection of the lateral rectus muscle (RR).
Intervention typeOther
Primary outcome measureThe variation of the latent angle of strabismus at distance at three months post-operatively between BR and RR.
Secondary outcome measures1. Reduction of convergence excess (larger angle of strabismus during near vision)
2. Binocular vision by means of Bagolini striated glasses
Overall study start date01/01/1998
Completion date31/12/2001

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Years
Upper age limit8 Years
SexBoth
Target number of participants124
Key inclusion criteriaEligible were all children aged three to eight years (either sex) with a normal psychophysical development, and onset of esotropia before one year of age who visited one of the clinics during the study period.
Key exclusion criteria1. Previous strabismus surgery
2. An angle of strabismus larger than 24° or smaller than 10°
3. Any normal binocular vision
4. Convergence excess with angle of strabismus at near fixation 15 times larger than the angle at distance
5. More than 1 line Logmar acuity difference between the two eyes
6. Hypermetropia over 6 diopters or myopia over 3 diopters
7. Up or down shoot in (25°) adduction more than 8°
8. V-pattern (25° up and down gaze) over 8°
9. A-pattern (25° up and down gaze) over 5°
10. Manifest vertical strabismus over 4°
Date of first enrolment01/01/1998
Date of final enrolment31/12/2001

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Centre Rotterdam
Rotterdam
3015 GD
Netherlands

Sponsor information

Erasmus Medical Centre (Netherlands)
University/education

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Website http://www.erasmusmc.nl/
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Hospital/treatment centre

Erasmus Medical Centre (Netherlands)

No information available

General Dutch Association Preventing Blindness (Algemene Nederlandse vereniging ter voorkoming van blindheid) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan