Demonstrate that compared to trabeculectomy, at 12 months follow-up:- a Baerveldt implant is not inferior with respect to IOP and- a Baerveldt implant is superior with respect to failure.
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- IOP at 12 montns.
- Failure rate at 12 months.
Secondary outcome
- IOP development during follow-up.
- Failure rate during follow-up.
- Need for supplemental medical therapy.
- Best corrected visual acuity (ETDRS).
- Visual field (HFA 24-2; SITA).
- Motility changes.
- Laser flare count.
- Incidence and type of complications.
Background summary
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.
Study objective
Demonstrate that compared to trabeculectomy, at 12 months follow-up:
- a Baerveldt implant is not inferior with respect to IOP and
- 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.
Intervention
Baerveldt implant vs. trabeculectomy.
Study burden and risks
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.
Schiedamse Vest 180
Rotterdam 3011BH
NL
Schiedamse Vest 180
Rotterdam 3011BH
NL
Listed location countries
Age
Inclusion criteria
- Age 18 - 75 years.
- Informed consent.
- Caucasian.
- Expected to complete follow-up of 5 years.
- Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma.
- Indication for IOP lowering surgery.
Exclusion criteria
- IOP exacerbating glaucoma by further delay of pressure reduction.
- Normal pressure glaucoma.
- History of ocular surgery.
- History of ocular comorbidity.
- Pregnant or nursing women.
- Functionally monocular patients.
- Need for glaucoma surgery combined with other ocular procedures or aniticipated need for additional ocular surgery.
- Narrow anterior chamber angle.
- Best corrected visual acuity less than 0.1.
- Severe blepharitis.
- History of strabismus.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL19835.078.07 |