(Cost-)effectiveness of MicroShunt versus Trabeculectomy
- Conditions
- Primary open-angle glaucoma
- Registration Number
- NL-OMON20100
- Lead Sponsor
- ZonMw
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 196
Caucasian, primary open angle glaucoma patients, between 18 and 80 years old, requiring standard trabeculectomy.
1.Patient unwilling or unable to give informed consent, unwilling to accept randomization or inability to complete follow-up (e.g. hospital visits) or comply with study procedures
2.Secondary glaucoma.
3.Previous incisional surgery of the subject eye. Previous uncomplicated clear corneal cataract surgery is allowed >6 months prior to the surgery.
4.Poor vision in either the study or fellow eye.
5.Any ocular comorbidities that could affect the visual field. .
6.Chronic or recurrent uveitis.
7.Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery.
8.Anatomical factors that increase the risk of complicated surgery.
9.Conditions that increase the risk of endophthalmitis.
10.Contraindication or allergy to mitomycin C.
11.Any contraindication to tube placement.
12.Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
13.Prior ocular laser treatment within 3 months of the surgery.
14.Corneal thickness <450um or >620microns.
15.Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy.
16.Among patients in whom both eyes are eligible only the first eye is undergoing surgical treatment is enrolled in the study.
17.Participation in another clinical study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is intraocular pressure after 12 months of follow-up.
- Secondary Outcome Measures
Name Time Method Secondary outcome measures are best corrected visual acuity, glaucoma medications, safety (complications and surgical interventions), visual fields, vision-related quality of life and generic health-related quality of life, and costs, cost-effectiveness and budget impact