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

Not Applicable

Recruiting

• Conditions: Glaucoma; Cataract

• Registration Number: NCT06844292
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-19
• Study First Posted: 2025-02-25
• Status Verified: 2025-03
• Study Start: 2025-03-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2027-03-03
• Study Completion: 2031-03-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure After Surgery	Baseline visit to 1 year	Mean IOP in mmHg one year after glaucoma surgery

Secondary Outcome Measures

Name	Time	Method
Intraocular Pressure at Other Follow-Up Time Points	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.
Anti-Hypertensive Medications Required	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
Best Corrected Visual Acuity	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.
Complete Success	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
Qualified Success	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
Endothelial Cell Density	Baseline visit and visit at year 1/2/3/4/5	Endothelial cell density will be measured with a specular microscope.
Assessment of Life Quality - Glaucoma Quality of Life-15 Questionnaire	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
Assessment of Life Quality - Ocular Surface Disease Index	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
Rate of Additional Ocular Surgery Post-Implantation	5 years	Rate of additional ocular surgery post-implantation will be collected at every study visit.
Rate of Complications or Incidents	5 years	Complications associated with both surgical procedures will be assessed.
Data From Optical Biometry - Axial Length	Baseline visit and year 1 visit	Axial Length of the eyeball from optical biometry will be measured.
Data From Optical Biometry - Anterior Chamber Depth	Baseline visit and year 1 visit	Anterior chamber depth from optical biometry will be measured.
Data From Optical Biometry - Corneal Surface Parameters	Baseline visit and year 1 visit	Corneal surface parameters (K-values) from optical biometry will be measured.
Standard Automated Perimetry	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.
Optical Coherence Tomography - RNFL Thickness	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.

Trial Locations

Locations (1)

Medical University Graz; 🇦🇹 Graz, Styria, Austria