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

Medical University of Graz

Status: Enrolling

Conditions: Cataract; Glaucoma

Treatments: Device: MINIject with Cataract Surgery; Device: Hydrus Microstent with Cataract Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06844292

1242/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

MINIject

Active Comparator group

Description:

MINIject with Cataract Surgery

Treatment:

Device: MINIject with Cataract Surgery

Hydrus Microstent

Active Comparator group

Description:

Hydrus Microstent with Cataract Surgery

Treatment:

Device: Hydrus Microstent with Cataract Surgery