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

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

Inclusion Criteria4

  • 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 Criteria5

  • 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

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.


Locations(1)

Medical University Graz

Graz, Styria, Austria

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NCT06844292


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