Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study aims to investigate postoperative outcomes after two different MIGS implants (MINIject or Hydrus) in combination with cataract surgery for patients with glaucoma.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINIject | Active Comparator | MINIject with Cataract Surgery |
|
| Hydrus Microstent | Active Comparator | Hydrus Microstent with Cataract Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure After Surgery | Mean IOP in mmHg one year after glaucoma surgery | Baseline visit to 1 year |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ewald Lindner, Prof. | Contact | +4331638580810 | ewald.lindner@medunigraz.at | |
| Lena M Haiden, MD | Contact | +4331638530798 | lena.haiden@medunigraz.at |
| Name | Affiliation | Role |
|---|---|---|
| Ewald Lindner, Prof. | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz | Recruiting | Graz | Styria | 8010 | Austria |
not necessary
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D002386 | Cataract |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
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 |
| 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 |
| 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 |