Bilateral recession or unilateral recession-resection as surgery for infantile esotropia
ISRCTN | ISRCTN72461159 |
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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
Scientific
Erasmus Medical Centre Rotterdam
Department of Ophthalmology
Room Ba 104
P.O. Box 2040
Rotterdam
3015 GD
Netherlands
simonsz@compuserve.com |
Study information
Study design | Multicentre randomised single-blind active controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A randomised comparison of bilateral recession with unilateral recession-resection as surgery for infantile esotropia |
Study acronym | BR vs RR |
Study objectives | 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(s) | Received from the local ethics committee |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/01/1998 |
Completion date | 31/12/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 3 Years |
Upper age limit | 8 Years |
Sex | Both |
Target number of participants | 124 |
Key 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. |
Key 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° |
Date of first enrolment | 01/01/1998 |
Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre Rotterdam
Rotterdam
3015 GD
Netherlands
3015 GD
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
University/education
University/education
Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
Website | http://www.erasmusmc.nl/ |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |