The hypothesis is that the MicroShunt will lead to a similar IOP lowering compared to trabeculectomy, and will be a cost-effective alternative for trabeculectomy.
ID
Bron
Verkorte titel
Aandoening
Primary open-angle glaucoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome measure is intraocular pressure after 12 months of follow-up.
Achtergrond van het onderzoek
The standard surgical treatment for glaucoma is trabeculectomy. The PRESERFLO™ (formerly InnFocus) MicroShunt is a new, minimally invasive drainage device which has been suggested to result in similar intraocular pressure 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.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) compared to trabeculectomy.
This is a multicenter, randomized, single blind, non-inferiority, interventional clinical trial, involving 10 medical centres in the Netherlands.
Doel van het onderzoek
The hypothesis is that the MicroShunt will lead to a similar IOP lowering compared to trabeculectomy, and will be a cost-effective
alternative for trabeculectomy.
Onderzoeksopzet
preoperative visit, 1 day, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperative.
Onderzoeksproduct en/of interventie
MicroShunt implantation augmented mitomycin C versus a standard trabeculectomy augmented with mitomycin C.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Caucasian, primary open angle glaucoma patients, between 18 and 80 years old, requiring standard trabeculectomy.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8356 |
| CCMO | NL68964.068.19 |
| OMON | NL-OMON52755 |