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

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

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Cataract
• Intervention / Treatment: Device: MINIject with Cataract Surgery; Device: Hydrus Microstent with Cataract Surgery

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.

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ewald Lindner, Prof.; Phone Number: +4331638580810; Email: ewald.lindner@medunigraz.at
• Study Contact Backup: Name: Lena M Haiden, MD; Phone Number: +4331638530798; Email: lena.haiden@medunigraz.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Recruiting
      • Medical University Graz
      • Contact: Ewald Lindner, Prof.; Phone Number: +4331638580810; Email: ewald.lindner@medunigraz.at
      • Contact: Lena M Haiden, MD; Email: lena.haiden@medunigraz.at
      • Principal Investigator: Ewald Lindner, Prof.
      • Sub-Investigator: Lena M Haiden, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MINIject; MINIject with Cataract Surgery	Device: 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.
Active Comparator: Hydrus Microstent; Hydrus Microstent with Cataract Surgery	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure After Surgery	Mean IOP in mmHg one year after glaucoma surgery	Baseline visit to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure at Other Follow-Up Time Points	IOP at other follow-up visits such as week 1, month 1/3/6 and year 2/3/4/5 after surgery.	Baseline visit to 5 years
Anti-Hypertensive Medications Required	Number and type of anti-hypertensive medications used at specific study visit	Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5
Best Corrected Visual Acuity	Best Corrected Visual Acuity will be measured with Snellen charts and will be transformed to logMAR.	Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5
Complete Success	Complete success is defined as either unmedicated IOP ≤21 mmHg, ≤18 mmHg, ≤15 and ≤12 mmHg and >5 mmHg	Baseline visit and visit at month 3/6 and year 1/2/3/4/5
Qualified Success	Qualified success is defined as either medicated IOP ≤21 mmHg, ≤18 mmHg, ≤15 and ≤12 mmHg and >5 mmHg	Baseline visit and visit at month 3/6 and year 1/2/3/4/5
Endothelial Cell Density	Endothelial cell density will be measured with a specular microscope.	Baseline visit and visit at year 1/2/3/4/5
Rate of Complications or Incidents	Complications associated with both surgical procedures will be assessed.	5 years
Data From Optical Biometry - Axial Length	Axial Length of the eyeball from optical biometry will be measured.	Baseline visit and year 1 visit
Data From Optical Biometry - Anterior Chamber Depth	Anterior chamber depth from optical biometry will be measured.	Baseline visit and year 1 visit
Data From Optical Biometry - Corneal Surface Parameters	Corneal surface parameters (K-values) from optical biometry will be measured.	Baseline visit and year 1 visit
Standard Automated Perimetry	Standard automated perimetry will be examined, the mean defect will be given in dB.	Baseline visit and visit at month 6 and year 1/2/3/4/5
Optical Coherence Tomography - RNFL Thickness	RNFL (retinal nerve fiber layer) thickness will be measured via OCT scan.	Baseline visit and visit at month 1/3/6 and year 1/2/3/4/5
Assessment of Life Quality - Glaucoma Quality of Life-15 Questionnaire	A modified Glaucoma Quality of Life-15 (GQL-15) Questionnaire will be used to determine and document quality of life. The GQL-15 questionnaire is a 15-item survey designed to assess the impact of glaucoma on a patient's daily life and well-being. It evaluates how symptoms like vision impairment, discomfort, and treatment affect daily activities. The scores range from 0 (Minimum) to 60 (Maximum), with higher scores indicating a greater negative impact on quality of life, while lower scores suggest less impairment. 0-15: Minimal impact on quality of life 16-30: Mild impact on quality of life 31-45: Moderate impact on quality of life 46-60: Severe impact on quality of life	Baseline visit and visit at month 6 and year 1/2/3/4/5
Assessment of Life Quality - Ocular Surface Disease Index	The Ocular Surface Disease Index (OSDI) will be used to determine and document quality of life. The OSDI is a 12-item questionnaire used to assess the severity of dry eye symptoms and their impact on daily life. The total score ranges from 0 (Minimum) to 100 (Maximum), with higher scores indicating more severe symptoms. 0-12: Minimal or no dry eye symptoms 13-22: Mild symptoms 23-32: Moderate symptoms 33-100: Severe symptoms	Baseline visit and visit at month 6 and year 1/2/3/4/5
Rate of Additional Ocular Surgery Post-Implantation	Rate of additional ocular surgery post-implantation will be collected at every study visit.	5 years

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Ewald Lindner, Prof., Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): March 3, 2031

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Cataract; Glaucoma; Open-angle Glaucoma; Minimally Invasive Glaucoma Surgery (MIGS); Intraocular Pressure (IOP) Reduction
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Ocular Hypertension; Cataract; Glaucoma
• Other Study ID Numbers: 1242/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not necessary

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No