search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


The Baerveldt Implant. Is postoperative ocular motility improved when conventional securing to the sclera is omitted?


- candidate number19571
- NTR NumberNTR4826
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-sep-2014
- Secondary IDsNL50037.078.14 OZR-2013-25
- Public TitleThe Baerveldt Implant. Is postoperative ocular motility improved when conventional securing to the sclera is omitted?
- Scientific TitleThe Baerveldt Implant. Is postoperative ocular motility improved when conventional securing to the sclera is omitted?
- ACRONYMBaerveldt implant & Ocular motility.
- hypothesisThe free plate technique in Baerveldt implant surgery reduces postoperative eye motility disturbance.
- Healt Condition(s) or Problem(s) studiedGlaucoma, Eye movements
- Inclusion criteria- Age 18 - 75 years.
- Informed consent.
- Caucasian.
- Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma.
- Exclusion criteria- Normal pressure glaucoma.
- History of ocular surgery.
- History of ocular comorbidity (e.g. active uveitis, proliferative diabetic retinopathy).
- Pregnant or nursing women.
- Functionally monocular patients.
- Need for glaucoma surgery combined with other ocular procedures or an anticipated need for additional ocular surgery.
- Narrow anterior chamber angle.
- Best corrected visual acuity less than 0.1.
- Severe blepharitis.
- History of strabismus.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2015
- planned closingdate31-dec-2017
- Target number of participants90
- InterventionsBaerveldt Implant (free plate).
- Primary outcomeIncidence of impaired ocular motility with or without diplopia at 3 months.
- Secondary outcome- Orthoptic parameters.
- Intraocular pressure.
- Failure rate at 12 months.
- Visual acuity.
- TimepointsPre-op, 1d, 2w, 6w, 3, 6, 12m.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. H.G. Lemij
- CONTACT for SCIENTIFIC QUERIESDr. H.G. Lemij
- Sponsor/Initiator Oogziekenhuis Rotterdam (OZR)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryBetween surgeons, techniques may differ in various degrees and for sundry reasons. One such difference is the suturing or no suturing of the plate of a Baerveldt implant to the sclera.
The objective is to monitor the effect of the free plate technique in Baerveldt implant surgery on the postoperative eye motility.
(This study is related to NTR1142; results will be compared.)
- Main changes (audit trail)
- RECORD30-sep-2014 - 22-okt-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl