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)


Primary Baerveldt glaucoma implant versus trabeculectomy study.


- candidate number2914
- NTR NumberNTR1142
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-nov-2007
- Secondary IDsOZR-2007-05 Oogziekenhuis RotterdamSchiedamsevest 1803011 BH Rotterdam
- Public TitlePrimary Baerveldt glaucoma implant versus trabeculectomy study.
- Scientific TitlePrimary Baerveldt glaucoma implant versus trabeculectomy study.
- ACRONYMN/A
- hypothesisA Baerveldt implant is a good alternative for trabeculectomy.
- Healt Condition(s) or Problem(s) studiedGlaucoma
- Inclusion criteria1. Age 18-75 years;
2. Informed consent;
3. Caucasian;
4. Expected to complete follow-up of 5 years;
5. Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma;
6. Indication for IOP lowering surgery.
- Exclusion criteria1. IOP exacerbating glaucoma by further delay of pressure reduction. (Because implant remains closed until 6 weeks post-op, assigning such a patient to the Baerveldt group would be unethical).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2008
- planned closingdate31-dec-2015
- Target number of participants180
- InterventionsBaerveldt implant vs. trabeculectomy.
- Primary outcome1. Intraocular pressure at 12 months;
2. Failure rate at 12 months.
- Secondary outcome1. IOP development during follow-up;
2. Failure rate during follow-up;
3. Need for supplemental medical therapy;
4. Best corrected visual acuity (ETDRS);
5. Visual field (HFA 24-2; SITA);
6. Motility changes;
7. Laser flare count;
8. Incidence and type of complications.
- Timepoints1. pre-op;
2. 1d;
3. 2w;
4. 6w;
5. 3m;
6. 6m;
7. 1y;
8. 2y;
9. 3y;
10. 4y;
11. 5y.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESdrs. P.W.T. Waard, de
- CONTACT for SCIENTIFIC QUERIESdrs. P.W.T. Waard, de
- Sponsor/Initiator Oogziekenhuis Rotterdam (OZR)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis
- PublicationsIslamaj E et al. Primary Baerveldt versus trabeculectomy study after one year follow-up. Acta Ophthalmol. Accepted for publication.
- Brief summaryRationale:
Presently, the only proven treatment of glaucoma is a reduction of intraocular pressure (IOP). Depending on severity, treatment options are medication, laser treatment or trabeculectomy. The latter is considered when other treatment modalities are ineffective. The results of a recent study suggest that a drainage device, such as the Baerveldt implant, may be a good alternative for trabeculectomy. Objective: Demonstrate that compared to trabeculectomy, at 12 months follow-up:
1. a Baerveldt implant is not inferior with respect to IOP and;
2. a Baerveldt implant is superior with respect to failure.
Study design:
This is a prospective, randomized, parallel group, open-label, monocenter study of patients with glaucoma.
Study population:
Glaucoma patients scheduled for trabeculectomy.
Intervention:
Baerveldt implant vs. trabeculectomy.
Main study parameters/endpoints:
IOP and failure rate at 12 montns.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Participants are scheduled for trabeculectomy. Visit schedule will be as for standard surgery. The control group will neither benefit from participating in this study, nor be at a greater risk than usual. It is expected that a Baerveldt implant is not inferior to trabeculectomy. The failure rate may be lower. It is conceivable, therefore, that the Baerveldt group may benefit from participating in this study, although the need for supplemental medical therapy may be higher. Study-related extra time for complete follow-up of 5 years will be 3.5 hours in total.
- Main changes (audit trail)12-sep-2014: "Sample size geamendeerd: van 2x90 naar 2x60" - AB
- RECORD27-nov-2007 - 22-okt-2017


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