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

NARecruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

March 3, 2025

Primary Completion Date

March 3, 2027

Study Completion Date

March 3, 2031

Conditions
GlaucomaCataract
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."

Trial Locations (1)

8010

RECRUITING

Medical University Graz, Graz

All Listed Sponsors
lead

Medical University of Graz

OTHER