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NCT Number: NCT06844292

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

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

Recruiting

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Key information

Conditions

Glaucoma Cataract Eye Diseases Glaucoma, Open-Angle Lens Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Graz

Graz, Styria, 8010, Austria

Location status: Recruiting

Location contact

Ewald Lindner, Prof.

CONTACT

[email protected]

+4331638580810

Ewald Lindner, Prof.

PRINCIPAL_INVESTIGATOR

Lena M Haiden, MD

CONTACT

[email protected]

Lena M Haiden, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MINIject with Cataract Surgery

Device

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

Device

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.

Primary outcomes

  1. Intraocular Pressure After Surgery

    Time frame: Baseline visit to 1 year

    Mean IOP in mmHg one year after glaucoma surgery

Secondary outcomes

  1. Intraocular Pressure at Other Follow-Up Time Points

    Time frame: Baseline visit to 5 years

    IOP at other follow-up visits such as week 1, month 1/3/6 and year 2/3/4/5 after surgery.

  2. Anti-Hypertensive Medications Required

    Time frame: Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5

    Number and type of anti-hypertensive medications used at specific study visit

  3. Best Corrected Visual Acuity

    Time frame: Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5

    Best Corrected Visual Acuity will be measured with Snellen charts and will be transformed to logMAR.

  4. Complete Success

    Time frame: Baseline visit and visit at month 3/6 and year 1/2/3/4/5

    Complete success is defined as either unmedicated IOP ≤21 mmHg, ≤18 mmHg, ≤15 and ≤12 mmHg and >5 mmHg

  5. Qualified Success

    Time frame: Baseline visit and visit at month 3/6 and year 1/2/3/4/5

    Qualified success is defined as either medicated IOP ≤21 mmHg, ≤18 mmHg, ≤15 and ≤12 mmHg and >5 mmHg

  6. Endothelial Cell Density

    Time frame: Baseline visit and visit at year 1/2/3/4/5

    Endothelial cell density will be measured with a specular microscope.

  7. 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

    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

  8. Assessment of Life Quality - Ocular Surface Disease Index

    Time frame: Baseline visit and visit at month 6 and year 1/2/3/4/5

    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

  9. Rate of Additional Ocular Surgery Post-Implantation

    Time frame: 5 years

    Rate of additional ocular surgery post-implantation will be collected at every study visit.

  10. Rate of Complications or Incidents

    Time frame: 5 years

    Complications associated with both surgical procedures will be assessed.

  11. Data From Optical Biometry - Axial Length

    Time frame: Baseline visit and year 1 visit

    Axial Length of the eyeball from optical biometry will be measured.

  12. Data From Optical Biometry - Anterior Chamber Depth

    Time frame: Baseline visit and year 1 visit

    Anterior chamber depth from optical biometry will be measured.

  13. Data From Optical Biometry - Corneal Surface Parameters

    Time frame: Baseline visit and year 1 visit

    Corneal surface parameters (K-values) from optical biometry will be measured.

  14. Standard Automated Perimetry

    Time frame: Baseline visit and visit at month 6 and year 1/2/3/4/5

    Standard automated perimetry will be examined, the mean defect will be given in dB.

  15. Optical Coherence Tomography - RNFL Thickness

    Time frame: Baseline visit and visit at month 1/3/6 and year 1/2/3/4/5

    RNFL (retinal nerve fiber layer) thickness will be measured via OCT scan.

Study contacts

Contact information is provided by the study sponsor or research team.

Ewald Lindner, Prof.

CONTACT

[email protected]

+4331638580810

Lena M Haiden, MD

CONTACT

[email protected]

+4331638530798

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Acronym: MINHY

Important dates

Study start
2025
Primary completion
2027
Study completion
2031
First posted
Feb 25, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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