The objective of this project is to aid in deciding on the use of the MicroShunt in glaucoma surgery by assessing its efficacy and cost-effectiveness in patients with primary open-angle glaucoma (POAG), pigment dispersion syndrome or ocular…
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
- Eye therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is IOP after 12 months of follow-up.
Secondary outcome
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.
Background summary
The standard surgical treatment for glaucoma is trabeculectomy. The MicroShunt
(MS) is a new, minimally invasive method which has been suggested to result in
similar IOP lowering, but with faster visual recovery and less complications
and postoperative interventions. However, this is based on limited evidence,
underscoring the need for a randomized controlled trial (RCT).
Study objective
The objective of this project is to aid in deciding on the use of the
MicroShunt in glaucoma surgery by assessing its efficacy and cost-effectiveness
in patients with primary open-angle glaucoma (POAG), pigment dispersion
syndrome or ocular hypertension compared to trabeculectomy (TE).
Study design
Multi-center, randomized, single blind, non-inferiority, interventional
clinical trial, involving 9 medical centers in the Netherlands.
Intervention
MicroShunt implantation augmented mitomycin C versus a standard trabeculectomy
augmented with mitomycin C.
Study burden and risks
Potential benefits of participating in this study (for patients allocated to
the MicroShunt implantation) are a shorter surgery duration, and a faster
recovery (e.g. of the visual acuity). Potential risks associated with
participation in this study are the potential risks of a standard
trabeculectomy. The most important complications are: hyphema, inflammation of
the anterior chamber, wound-/or bleb-leakage, shallow anterior chamber,
hypotony and hypotony maculopathy, suprachoroidal hemorrhage or choroidal
effusion syndrome, and endophthalmitis. There is also an increased risk of
developing cataract after the surgery. The risk of one of these complications
is expected to be either similar for both surgeries or lower for the MicroShunt
implantation. However this is based on the little evidence, that is currently
available. Compared to usual care, the extra burden for all patients
participating in this study is filling in questionnaires five times during the
study, which will take 20 to 30 minutes per time.
P. Debyelaan 25 25
Maastricht 6229 HX
NL
P. Debyelaan 25 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
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).
Exclusion criteria
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.
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
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03931564 |
| CCMO | NL68964.068.19 |
| OMON | NL-OMON20100 |