Evaluation of Microinvasive Glaucoma Surgery: MINIject® Versus Hydrus® Microstent in Combination With Cataract Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MINIject with Cataract Surgery, Hydrus Microstent with Cataract Surgery.
- Who it may be relevant to
- Registry conditions: Glaucoma, Cataract. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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. Catarac - 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.
Primary outcome measures
- Intraocular Pressure After Surgery [Time frame: Baseline visit to 1 year]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- Medical University Graz — Graz
Identifiers
NCT: NCT06844292 · 1242/2024