NCT04323930

eyeWatch vs. Trabeculectomy RCT (evT)

Randomized Control Trial of the eyeWatch System as a First-Line Surgical Treatment of Glaucoma vs. MMC-Trabeculectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Dr. Kaweh Mansouri · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The confirm the performance and safety of the eyeWatch System as first-line filtering surgery and compare its outcomes to trabeculectomy

Detailed description

Open-angle glaucoma is an ophthalmic disease often characterised by high intraocular pressures. Traditionally, glaucoma is treated using medication, however, more advanced or refractory glaucoma requires surgical treatment. In terms of surgery, the current gold-standard is trabeculectomy. Despite good efficacy, the technique carries relatively high rates of complications. The eyeWatch system has recently received CE-marking for the treatment of open-angle glaucoma. During its initial clinical trial, the eyeWatch system demonstrated good safety and efficacy profile. The present randomized control trial will assess its safety and efficacy against the current gold-standard: trabeculectomy.

Conditions

• Primary Glaucoma

Interventions

Type	Name	Description
DEVICE	eyeWatch	The eyeWatch system will be implanted as per the manufacturer's instruction, and trabeculectomy will be performed using mitomycin C as per standard surgical protocols.

Timeline

• Start date: 2021-06-30
• Primary completion: 2022-06-30
• Completion: 2023-12-31
• First posted: 2020-03-27
• Last updated: 2022-05-10

Locations

1 site across 1 country: Switzerland