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The Baerveldt Implant. Corneal endothelial changes and tube position.


- candidate number21301
- NTR NumberNTR4946
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jan-2015
- Secondary IDsNL51175.078.14 OZR 2014-22
- Public TitleThe Baerveldt Implant. Corneal endothelial changes and tube position.
- Scientific TitleThe Baerveldt Implant. Corneal endothelial changes and tube position.
- ACRONYM
- hypothesisTo determine the effect of tube position in the anterior chamber on the corneal endothelium.
- Healt Condition(s) or Problem(s) studiedGlaucoma
- Inclusion criteria- Age 18-75 years. - Informed consent. - Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma.
- Exclusion criteria- History of intraocular surgery (i.e. strabismus surgery, tenonís capsule or conjunctiva surgery, cataract surgery, cyclodestructive procedures etc.). - 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 (i.e. cataract surgery, keratoplasty, or retinal surgery) or an anticipated need for additional ocular surgery. - Best corrected visual acuity less than 0.1.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2015
- planned closingdate31-dec-2017
- Target number of participants200
- Interventionsnone
- Primary outcomeCorrelation between endothelial cell counts and tube position.
- Secondary outcome- Pachymetry. - Cell morphology (polymegathism, pleomorphism). - Stromal changes. - Tube length. - Tube bevel. - Corneal decompensation.
- Timepointspre-op, 1d,2w,6w,12m,24m
- 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 summaryRationale: Implantation of the Baerveldt glaucoma drainage device is a common procedure for glaucoma management. A silicon tube is then put in the anterior chamber of the eye. Postoperative corneal endothelial changes, notably a reduction in endothelial cell count are quite common, sometimes leading to corneal decompensation requiring corneal transplant surgery. It is unclear to what extent tube position in the anterior chamber plays a role in the pathogenesis of the corneal changes. Objective: To determine the effect of tube position in the anterior chamber on the corneal endothelium. Study design: Prospective observational. Study population: Glaucoma patients scheduled for a Baerveldt implant. Main study parameter: Correlation between endothelial cell counts and tube position. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation does not involve any additional risk. Burden is limited to the additional time needed for extra measurements. These assessments will be performed at the time of regular visits and take about one hour extra time (5X).
- Main changes (audit trail)
- RECORD6-jan-2015 - 22-okt-2017


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