GlaucomaMINHYNCT06844292
Evaluation of Microinvasive Glaucoma Surgery: MINIject® Versus Hydrus® Microstent in Combination With Cataract Surgery
A study testing MINIject with Cataract Surgery and Hydrus Microstent with Cataract Surgery in people with Glaucoma and Cataract, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- MINIject with Cataract Surgery and Hydrus Microstent with Cataract Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteAustria
- Study dates
- 3 Mar 2025to 3 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University Graz
Graz, Styria, 8010
Ewald Lindner, Prof., +4331638580810, ewald.lindner@medunigraz.at
Lena M Haiden, MD, lena.haiden@medunigraz.at
About this study
The study aims to investigate postoperative outcomes after two different MIGS implants (MINIject or Hydrus) in combination with cataract surgery for patients with glaucoma.
Read the 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.
- Being tested
- MINIject with Cataract Surgery, Hydrus Microstent with Cataract Surgery
- Keywords
- Glaucoma, Open-angle Glaucoma, Cataract, Minimally Invasive Glaucoma Surgery (MIGS), Intraocular Pressure (IOP) Reduction
- Medical subject headings
- Glaucoma, Cataract, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINIject with Cataract SurgeryDevice
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 SurgeryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MINIject | Active comparator | MINIject with Cataract Surgery Receives: Device: MINIject with Cataract Surgery |
| Hydrus Microstent | Active comparator | Hydrus Microstent with Cataract Surgery Receives: Device: Hydrus Microstent with Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure After Surgery
Mean IOP in mmHg one year after glaucoma surgery
Measured: Baseline visit to 1 year
Secondary outcomes (15)
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.
Measured: Baseline visit to 5 years
Anti-Hypertensive Medications Required
Number and type of anti-hypertensive medications used at specific study visit
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline visit and visit at 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
Measured: 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
Measured: 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.
Measured: 5 years
Rate of Complications or Incidents
Complications associated with both surgical procedures will be assessed.
Measured: 5 years
Data From Optical Biometry - Axial Length
Axial Length of the eyeball from optical biometry will be measured.
Measured: Baseline visit and year 1 visit
Data From Optical Biometry - Anterior Chamber Depth
Anterior chamber depth from optical biometry will be measured.
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.
Measured: Baseline visit and year 1 visit
Standard Automated Perimetry
Standard automated perimetry will be examined, the mean defect will be given in dB.
Measured: 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.
Measured: Baseline visit and visit at month 1/3/6 and year 1/2/3/4/5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start3 Mar 2025
- Primary completion3 Mar 2027 (estimated)
- Study completion3 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewald Lindner, Prof., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844292
- Sponsor's protocol ID
- 1242/2024
- Acronym
- MINHY
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not necessary
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Microinvasive Glaucoma Surgery: MINIject® Versus Hydrus® Microstent in Combination With Cataract Surgery
- ClinicalTrials.gov ID
- NCT06844292
- Acronym / sponsor ID
- MINHY / 1242/2024
- Keywords
- Glaucoma, Open-angle Glaucoma, Cataract, Minimally Invasive Glaucoma Surgery (MIGS), Intraocular Pressure (IOP) Reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 3 Mar 2027 (estimated)
- Study completion
- 3 Mar 2031 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MINIject | Active comparator | Device: MINIject with Cataract SurgeryMINIject with Cataract Surgery |
| Hydrus Microstent | Active comparator | Device: Hydrus Microstent with Cataract SurgeryHydrus Microstent with Cataract Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MINIject with Cataract SurgeryPatients 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. | Device | MINIject |
| Hydrus Microstent with Cataract SurgeryPatients 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. | Device | Hydrus Microstent |
Primary outcome
Intraocular Pressure After Surgery
Time frame: Baseline visit to 1 year
Mean IOP in mmHg one year after glaucoma surgery
15 secondary outcomes
Intraocular Pressure at Other Follow-Up Time Points
Time frame: Baseline visit to 5 years
Anti-Hypertensive Medications Required
Time frame: Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5
Best Corrected Visual Acuity
Time frame: Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5
Complete Success
Time frame: Baseline visit and visit at month 3/6 and year 1/2/3/4/5
Qualified Success
Time frame: Baseline visit and visit at month 3/6 and year 1/2/3/4/5
Endothelial Cell Density
Time frame: Baseline visit and visit at year 1/2/3/4/5
Assessment of Life Quality - Glaucoma Quality of Life-15 Questionnaire
Time frame: Baseline visit and visit at month 6 and year 1/2/3/4/5
Assessment of Life Quality - Ocular Surface Disease Index
Time frame: Baseline visit and visit at month 6 and year 1/2/3/4/5
Rate of Additional Ocular Surgery Post-Implantation
Time frame: 5 years
Rate of Complications or Incidents
Time frame: 5 years
Data From Optical Biometry - Axial Length
Time frame: Baseline visit and year 1 visit
Data From Optical Biometry - Anterior Chamber Depth
Time frame: Baseline visit and year 1 visit
Data From Optical Biometry - Corneal Surface Parameters
Time frame: Baseline visit and year 1 visit
Standard Automated Perimetry
Time frame: Baseline visit and visit at month 6 and year 1/2/3/4/5
Optical Coherence Tomography - RNFL Thickness
Time frame: Baseline visit and visit at month 1/3/6 and year 1/2/3/4/5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No. not necessary
Related trials for Glaucoma
Recruiting
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
Corneal Transplantation, Glaucoma
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Not yet recruitingPhase 2
VGFTe-(HD)-OD-2566: Adjunctive Aflibercept Ahmed Glaucoma Valve (AAA) Study
Glaucoma
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
RecruitingPhase 1/2
A Study About the Safety of ASP2767 and Whether it Helps People With Glaucoma-Related Optic Nerve Damage
Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ewald Lindner, Prof. principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINIject with Cataract Surgery and Hydrus Microstent with Cataract Surgery in people with Glaucoma and Cataract, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ewald Lindner, Prof. (+4331638580810, ewald.lindner@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure After Surgery (time frame: Baseline visit to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.