RecruitingNot ApplicableNCT06844292

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

Sponsor

Medical University of Graz

Enrollment

152 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Cataract Glaucoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two small implants used in minimally invasive glaucoma surgery — the MINIject and the Hydrus microstent — both combined with cataract surgery, to see which one better lowers eye pressure over time in people with both glaucoma and cataracts. **You may be eligible if...** - You have glaucoma that requires surgery to reach your target eye pressure - You also have cataracts that need surgery - You are over 18 years old and otherwise eligible for both surgeries - You are willing to attend follow-up visits for at least 12 months **You may NOT be eligible if...** - You have certain types of glaucoma not suitable for these implants (e.g., angle-closure, uveitic, or neovascular glaucoma) - You are expected to need additional eye surgery soon - You are unwilling or unable to attend follow-up appointments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMINIject 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.

DEVICEHydrus 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.