|- candidate number||2914|
|- NTR Number||NTR1142|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-nov-2007|
|- Secondary IDs||OZR-2007-05 Oogziekenhuis RotterdamSchiedamsevest 1803011 BH Rotterdam|
|- Public Title||Primary Baerveldt glaucoma implant versus trabeculectomy study.|
|- Scientific Title||Primary Baerveldt glaucoma implant versus trabeculectomy study.|
|- hypothesis||A Baerveldt implant is a good alternative for trabeculectomy.|
|- Healt Condition(s) or Problem(s) studied||Glaucoma|
|- Inclusion criteria||1. Age 18-75 years;|
2. Informed consent;
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 criteria||1. 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2008|
|- planned closingdate||31-dec-2015|
|- Target number of participants||180|
|- Interventions||Baerveldt implant vs. trabeculectomy.|
|- Primary outcome||1. Intraocular pressure at 12 months;|
2. Failure rate at 12 months.
|- Secondary outcome||1. 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.
|- Timepoints||1. pre-op;|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||drs. P.W.T. Waard, de|
|- CONTACT for SCIENTIFIC QUERIES||drs. P.W.T. Waard, de|
|- Sponsor/Initiator ||Oogziekenhuis Rotterdam (OZR)|
(Source(s) of Monetary or Material Support)
|Stichting Wetenschappelijk Onderzoek het Oogziekenhuis|
|- Publications||Islamaj E et al. Primary Baerveldt versus trabeculectomy study after one year follow-up. Acta Ophthalmol. Accepted for publication.|
|- Brief summary||Rationale: |
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.
This is a prospective, randomized, parallel group, open-label, monocenter study of patients with glaucoma.
Glaucoma patients scheduled for trabeculectomy.
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|
|- RECORD||27-nov-2007 - 22-okt-2017|