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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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