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

Last updated: March 11, 2025
Sponsor: Medical University of Graz
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Vision Loss

Glaucoma

Treatment

Hydrus Microstent with Cataract Surgery

MINIject with Cataract Surgery

Clinical Study ID

NCT06844292
1242/2024
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients with glaucoma in which surgery is indicated to reach target intraocularpressure 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

Exclusion Criteria:

  • Patients who do not want to make follow-ups at the department

  • Angle closure, uveitic, neovascular, congenital glaucoma, iridocorneal endothelialsyndrome, Axenfeld-Rieger syndrome

  • Prior filtering glaucoma surgery, suprachoroidal stent, retinal surgery, cornealgraft surgery or cyclophotocoagulation

  • Allergy to any drugs or substances required for the protocol

  • Pregnant women

Study Design

Total Participants: 152
Treatment Group(s): 2
Primary Treatment: Hydrus Microstent with Cataract Surgery
Phase:
Study Start date:
March 03, 2025
Estimated Completion Date:
March 03, 2031

Study 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.

Connect with a study center

  • Medical University Graz

    Graz, Styria 8010
    Austria

    Active - Recruiting

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