NCT06844292

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study aims to investigate postoperative outcomes in terms of intraocular pressure as well as safety measures after two different MIGS implants (MINIject® or Hydrus®) in conjunction with cataract surgery (CS) for patients with chronic glaucoma. The patients will be followed up for 5 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination and ocular imaging with OCT (Optical Coherence Tomography). Assessment of life quality as well as adverse events will be performed.

Conditions

• Glaucoma
• Cataract

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-03
• Primary completion: 2027-03-03
• Completion: 2031-03-03
• First posted: 2025-02-25
• Last updated: 2025-03-14

Locations

1 site across 1 country: Austria