Primary Baerveldt glaucoma implant versus trabeculectomy study.

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.

A Baerveldt implant is a good alternative for trabeculectomy.

1. pre-op;

2. 1d;

3. 2w;

4. 6w;

5. 3m;

6. 6m;

7. 1y;

8. 2y;

9. 3y;

10. 4y;

11. 5y.

Baerveldt implant vs. trabeculectomy.