Comparing two microinvasive glaucoma surgeries with cataract surgery
Evaluation of Microinvasive Glaucoma Surgery: MINIject® Versus Hydrus® Microstent in Combination With Cataract Surgery
This study tests which of two new glaucoma surgeries, MINIject or Hydrus, works better when done with cataract surgery for people with chronic glaucoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz, Styria) |
| Trial ID | NCT06844292 on ClinicalTrials.gov |
What this trial studies
This study investigates the postoperative outcomes of two different microinvasive glaucoma surgery implants, MINIject and Hydrus, when performed alongside cataract surgery in patients with chronic glaucoma. Participants will be monitored for five years, with assessments including intraocular pressure measurements, fundus examinations, and ocular imaging using Optical Coherence Tomography (OCT). The study also evaluates quality of life and records any adverse events that may occur during the follow-up period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with glaucoma requiring surgery to achieve target intraocular pressure and who also have lens opacities necessitating cataract surgery.
Not a fit: Patients with specific types of glaucoma such as angle closure or those who have had prior glaucoma surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective surgical approach for managing glaucoma in patients undergoing cataract surgery.
How similar studies have performed: Previous studies have shown promising results with microinvasive glaucoma surgeries, suggesting potential benefits in similar approaches.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Graz, Styria
- Medical University Graz — Graz, Styria, Austria (Recruiting)
Study contacts
- Principal investigator: Ewald Lindner, Prof. — Medical University of Graz
- Study coordinator: Ewald Lindner, Prof.
- Email: ewald.lindner@medunigraz.at
- Phone: +4331638580810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.