Evaluation of Microinvasive Glaucoma Surgery: MINIject® Versus Hydrus® Microstent in Combination With Cataract Surgery
NCT ID: NCT06844292
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
152 participants
INTERVENTIONAL
2025-03-03
2031-03-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MINIject
MINIject with Cataract Surgery
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.
Hydrus Microstent
Hydrus Microstent with Cataract Surgery
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Clinically eligible for both surgeries
* Subjects not anticipated to require any further surgery in the next 12 months
* Patients' age \> 18 years
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Ewald Lindner, Prof.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
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Medical University Graz
Graz, Styria, Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1242/2024
Identifier Type: -
Identifier Source: org_study_id
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