No registrations found.
ID
Source
Brief title
Health condition
Glaucoma.
Sponsors and support
Schiedamsevest 180
3011 BH Rotterdam
Intervention
Outcome measures
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.
Background 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.
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.
Study objective
A Baerveldt implant is a good alternative for trabeculectomy.
Study design
1. pre-op;
2. 1d;
3. 2w;
4. 6w;
5. 3m;
6. 6m;
7. 1y;
8. 2y;
9. 3y;
10. 4y;
11. 5y.
Intervention
Baerveldt implant vs. trabeculectomy.
Schiedamsevest 180
P.W.T. Waard, de
Rotterdam 3011 BH
The Netherlands
+31(0)10 4017777
deWaard@oogziekenhuis.nl
Schiedamsevest 180
P.W.T. Waard, de
Rotterdam 3011 BH
The Netherlands
+31(0)10 4017777
deWaard@oogziekenhuis.nl
Inclusion criteria
1. 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 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).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1108 |
| NTR-old | NTR1142 |
| Other | Oogziekenhuis RotterdamSchiedamsevest 1803011 BH Rotterdam : OZR-2007-05 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Summary results
PMID: 30022618
<br>
Islamaj E, Jordaan-Kuip CP, Vermeer KA, Lemij HG, de Waard PWT. Motility Changes and Diplopia After Baerveldt Glaucoma Drainage Device Implantation or After Trabeculectomy. Trans Vis Sci Tech. 2018; 7(5): 7.
PMID: 30221073
<br>
Islamaj E, Wubbels RJ, de Waard PWT. Primary Baerveldt versus Trabeculectomy study after 5 years of follow-up. Acta Ophthalmol. 2020; 98(4): 400-407.
PMID: 31729825
<br>