NCT04503356

OMNI in Open-angle Glaucoma Treatment

Evaluation of the Effectiveness of the New Surgical Method OMNI in the Treatment of Adult Patients With Open-angle Glaucoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Centre of Postgraduate Medical Education · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single-center, prospective study will assess safety and effectiveness of 360 degree viscodilation followed by up to 360 degree trabeculotomy used in patients with early or moderate open-angle glaucoma in a real-world setting either as a standalone procedure in pseudophakic patients (or phakic) or combined with phacoemulsification cataract procedures. Medication usage, IOP and secondary surgical procedures necessary for IOP control will be analyzed during the follow-up period.

Conditions

• Open Angle Glaucoma
• Cataract
• Eye Diseases
• Glaucoma

Interventions

Type	Name	Description
PROCEDURE	OMNI as a standalone procedure	It uses a single, self-sealing clear corneal incision with ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System as a standalone procedure.
PROCEDURE	OMNI combined with cataract surgery	Phacoemulsification with intraocular lens implantation is performed. Then, ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System.

Timeline

• Start date: 2018-04-17
• Primary completion: 2019-12-03
• Completion: 2021-12-01
• First posted: 2020-08-07
• Last updated: 2020-08-11

Locations

1 site across 1 country: Poland