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RECRUITING
NCT06844292
NA

Evaluation of Microinvasive Glaucoma Surgery: MINIject® Versus Hydrus® Microstent in Combination With Cataract Surgery

Sponsor: Medical University of Graz

View on ClinicalTrials.gov

Summary

The study aims to investigate postoperative outcomes after two different MIGS implants (MINIject or Hydrus) in combination with cataract surgery for patients with glaucoma.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2025-03-03

Completion Date

2031-03-03

Last Updated

2025-03-14

Healthy Volunteers

No

Interventions

DEVICE

MINIject with Cataract Surgery

Patients will be randomized to receive either a MINIject implant or a Hydrus Microstunt in conjunction with cataract surgery. If randomized to MINIject, the device will be implanted into the supraciliary space with a minimally invasive ab interno approach. It is designed to be implanted with its head in the anterior chamber and its body in the supraciliary space, leading to improved natural uveoscleral outflow by directing aqueous humor from the anterior chamber to the sub-scleral space. Cataract surgery will be performed with phacoemulsification.

DEVICE

Hydrus Microstent with Cataract Surgery

Patients will be randomized to receive either a Hydrus Microstunt or a MINIject implant in conjunction with cataract surgery. If randomized to Hydrus Microstent, the device will be implanted into Schlemm's canal through the trabecular meshwork in order to dilate and restore the natural aqueous outflow pathway through Schlemm's canal, leading to a reduction of intraocular pressure. Cataract surgery will be performed with phacoemulsification.

Locations (1)

Medical University Graz

Graz, Styria, Austria