Clinical trial NCT06844292: Evaluation of Microinvasive Glaucoma Surgery: MINIject® Versus Hydrus® Microstent in Combination With Cataract Surgery
Official title: Evaluation of Microinvasive Glaucoma Surgery: MINIject® Versus Hydrus® Microstent in Combination With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Cataract
Keywords: Glaucoma
Open-angle Glaucoma
Cataract
Minimally Invasive Glaucoma Surgery (MIGS)
Intraocular Pressure (IOP) Reduction
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Device: Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS), either Hydrus Microstent or MINIject. The patients will be randomized (1:1) to each treatment/intervention arm.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraocular Pressure After Surgery
timeFrame: Baseline visit to 1 year
Secondary outcomes:
measure: Intraocular Pressure at Other Follow-Up Time Points
timeFrame: Baseline visit to 5 years
measure: Anti-Hypertensive Medications Required
timeFrame: Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5
measure: Best Corrected Visual Acuity
timeFrame: Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5
measure: Complete Success
timeFrame: Baseline visit and visit at month 3/6 and year 1/2/3/4/5
measure: Qualified Success
timeFrame: Baseline visit and visit at month 3/6 and year 1/2/3/4/5
measure: Endothelial Cell Density
timeFrame: Baseline visit and visit at year 1/2/3/4/5
measure: Assessment of Life Quality - Glaucoma Quality of Life-15 Questionnaire
timeFrame: Baseline visit and visit at month 6 and year 1/2/3/4/5
measure: Assessment of Life Quality - Ocular Surface Disease Index
timeFrame: Baseline visit and visit at month 6 and year 1/2/3/4/5
measure: Rate of Additional Ocular Surgery Post-Implantation
timeFrame: 5 years
measure: Rate of Complications or Incidents
timeFrame: 5 years
measure: Data From Optical Biometry - Axial Length
timeFrame: Baseline visit and year 1 visit
measure: Data From Optical Biometry - Anterior Chamber Depth
timeFrame: Baseline visit and year 1 visit
measure: Data From Optical Biometry - Corneal Surface Parameters
timeFrame: Baseline visit and year 1 visit
measure: Standard Automated Perimetry
timeFrame: Baseline visit and visit at month 6 and year 1/2/3/4/5
measure: Optical Coherence Tomography - RNFL Thickness
timeFrame: Baseline visit and visit at month 1/3/6 and year 1/2/3/4/5
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Ewald Lindner, Prof.
role: PRINCIPAL_INVESTIGATOR
References: