Effectiveness and cost-effectiveness of MicroShunt (MS) implantation versus standard trabeculectomy (TE)
- Conditions
- glaucoma1001830710015957
- Registration Number
- NL-OMON52755
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 124
Adult Caucasian patients aged between 18 and 80 years old with uncontrolled
open-angle glaucoma (pigment dispersion syndrome and pseudo exfoliation
syndrome allowed) or ocular hypertension on (maximum tolerated) medical therapy
and/or progression with an indication for primary glaucoma surgery
(trabeculectomy) are suitable for inclusion.
Open-angle glaucoma is defined as an open drainage angle (>= Shaffer grade II,
trabecular meshwork visible in 360 degrees).
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 (e.g. iris neovascularization, rubeosis iridis, trauma,
epithelial or fibrous down growth, iridocorneal endothelial syndrome).
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. Poor vision is defined as a
corrected vis-ual acuity <0.5, with the exception of pre-existent amblyopia of
the study eye (<0.2), and/or a mean deviation worse than -20dB on the visual
field.
5. Any ocular comorbidities that could affect the visual field. (e.g. diabetic
retinopathy, proliferative retinopathy, aphakia, degenerative visual disorder
not associated with glaucoma)
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 (due to
previous trauma, anatomical abnormalities, anterior synechiae or previous
cyclodestructive procedure).
9. Conditions that increase the risk of endophthalmitis.
- Current ocular, adnexal or periocular infections (e.g., untreated severe
blepha-ritis)
- Immune compromised patients including the use of topical or systemic steroids
for an indication other than the surgery within 3 months of the procedure (this
would not include the use of inhaled or dermatologic steroids), chemotherapy
within 6 months of the procedure.
- Iodine allergy
- Unwilling to temporarily discontinue contact lens after surgery
10. Contraindication or allergy to mitomycin C.
11. Any contraindication to tube placement (e.g. shallow anterior chamber,
insufficient endothelial cell density).
12. Use of oral hypotensive glaucoma medications for treatment of the fellow
eye.
13. Prior ocular laser treatment within 3 months of the surgery, increasing the
risk of inflammation in the eye.
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 <p>The primary outcome measure is IOP after 12 months of follow-up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are best corrected visual acuity, glaucoma<br /><br>medications, safety (complications and surgical interventions), visual fields,<br /><br>vision-related quality of life and generic health-related quality of life, and<br /><br>costs, cost-effectiveness and budget impact.</p><br>