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
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