Condition category
Eye Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
28/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof H J Simonsz

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR333

Study information

Scientific title

A randomised comparison of bilateral recession with unilateral recession-resection as surgery for infantile esotropia

Acronym

BR vs RR

Study hypothesis

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). 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

Received from the local ethics committee

Study design

Multicentre randomised single-blind active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Infantile esotropia

Intervention

Bilateral recession of the medial rectus muscles (BR) and unilateral recession of the medial rectus muscle and resection of the lateral rectus muscle (RR).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The variation of the latent angle of strabismus at distance at three months post-operatively between BR and RR.

Secondary outcome measures

1. Reduction of convergence excess (larger angle of strabismus during near vision)
2. Binocular vision by means of Bagolini striated glasses

Overall trial start date

01/01/1998

Overall trial end date

31/12/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible 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.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

124

Participant exclusion criteria

1. 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°

Recruitment start date

01/01/1998

Recruitment end date

31/12/2001

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre Rotterdam
Rotterdam
3015 GD
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

http://www.erasmusmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes