Recruiting

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

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

ClinicalTrials.gov IDNCT06844292

PhaseNA

Enrollment152

SponsorMedical University of Graz

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Glaucoma, Cataract

About this study

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

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.

Primary outcomes

Intraocular Pressure After Surgery (Baseline visit to 1 year)

Eligibility information

Inclusion Criteria: * Patients with glaucoma in which surgery is indicated to reach target intraocular pressure as well as lens opacities where CS is indicated * Clinically eligible for both surgeries * Subjects not anticipated to require any further surgery in the next 12 months * Patients' age \> 18 years Exclusion Criteria: * Patients who do not want to make follow-ups at the department * Angle closure, uveitic, neovascular, congenital glaucoma, iridocorneal endothelial syndrome, Axenfeld-Rieger syndrome * Prior filtering glaucoma surgery, suprachoroidal stent, retinal surgery, corneal graft surgery or cyclophotocoagulation * Allergy to any drugs or substances required for the protocol * Pregnant women

Study locations

Medical University Graz, Graz, Styria 8010 Austria

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-15.