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The effects of squint surgery on double vision and abnormal head posture in patients with Graves eye disease.


- candidate number14229
- NTR NumberNTR3796
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jan-2013
- Secondary IDs1001 AMC
- Public TitleThe effects of squint surgery on double vision and abnormal head posture in patients with Graves eye disease.
- Scientific TitleOutcome of strabismus surgery in patients with Graves’ Orbitopathy: A prospective multicenter study.
- ACRONYMGINTS study
- hypothesisThere is a significant correlation between the changes in the field of binocular single vision and the quality of life measured with the GO-QoL and the TED-QoL.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria1. GO-patients, who are clinically and biochemically euthyroid for at least three months;
2. GO-patients, who show a stable orthoptic picture for at least three months: Stable means no greater than 5 prism dioptres change in primary position and no greater change in duction as 8°.
- Exclusion criteria1. GO-patients with suppression (inhibition of the image of the deviating eye in the visual cortex);
2. Presence of previously diagnosed and/or treated for squint not related to the thyroid;
3. Presence of vision less than 0,2 for one or both eyes.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 31-jan-2013
- planned closingdate31-dec-2013
- Target number of participants40
- InterventionsStrabismus surgery.
- Primary outcomePrimary outcome measure will be the correlation between the changes in the field of BSV and QoL.
- Secondary outcomeSecondary outcomes will be the influence on primary outcome of squint angle, ductions and cyclodeviation. Also, the influence of prior treatment (for instance orbital decompression) on field of BSV, change in proptosis and lid aperture and the number of complications will be recorded.
- Timepoints3 months postoperatively.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. H.M. Jellema
- CONTACT for SCIENTIFIC QUERIESDrs. H.M. Jellema
- Sponsor/Initiator Academic Medical Center (AMC), Department of Ophtalmology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryTo evaluate the outcome of strabismus surgery in Graves’ Orbitopathy patients on binocular function and quality of life.
- Main changes (audit trail)
- RECORD18-jan-2013 - 9-feb-2013


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