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van CCT (UK)


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van CCT (UK)


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


- candidate number1528
- NTR NumberNTR333
- ISRCTNISRCTN72461159
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitleA randomized comparison of bilateral recession with unilateral recession-resection as surgery for infantile esotropia.
- Scientific TitleBilateral recession or unilateral recession-resection as surgery for infantile esotropia.
- ACRONYMBR vs RR
- hypothesisInfantile 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.
- Healt Condition(s) or Problem(s) studiedInfantile esotropia
- Inclusion criteriaEligible were all children aged three to eight years with a normal psychophysical development, and onset of esotropia before age 1 who visited one of the clinics during the study period.
- Exclusion criteriaPrevious 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-1998
- planned closingdate31-dec-2001
- Target number of participants124
- InterventionsBilateral recession of the medial rectus muscles (BR) and unilateral recession of the medial rectus muscle and resection of the lateral rectus muscle (RR).
- Primary outcomeThe variation of the latent angle of strabismus at distance at three months postoperatively between BR and RR.
- Secondary outcomeReduction of convergence excess (larger angle of strabismus during near vision) Binocular vision by means of Bagolini striated glasses.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. H.J. Simonsz
- CONTACT for SCIENTIFIC QUERIESProf. Dr. H.J. Simonsz
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Algemene Nederlandse vereniging ter voorkoming van blindheid
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD12-sep-2005 - 20-mei-2008


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