Evaluating visual field changes after PreserFlo MicroShunt implantation for glaucoma
Visual Field Progression and RNFL Change After PreserFlo MicroShunt Implantation - a Prospective Cohort Study at the Ophthalmology Department Klinikum Klagenfurt
This study is testing how well the PreserFlo MicroShunt surgery helps improve vision and eye health in people with glaucoma who aren't getting enough relief from other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Klinikum Klagenfurt am Wörthersee Academic / other |
| Locations | 1 site (Klagenfurt) |
| Trial ID | NCT06174324 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the progression of visual fields and changes in retinal nerve fiber layer (RNFL) thickness following the implantation of the PreserFlo MicroShunt in patients with glaucoma. The study will focus on patients who have not achieved adequate intraocular pressure control despite existing treatments. By monitoring structural and functional changes post-implantation, the research seeks to provide insights into the effectiveness of this surgical approach compared to traditional methods like trabeculectomy.
Who should consider this trial
Good fit: Ideal candidates include patients with primary open angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma, or normal tension glaucoma who have insufficient eye pressure control.
Not a fit: Patients who have previously undergone glaucoma surgery or have severe visual impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of glaucoma with reduced risk of complications and better preservation of vision.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with insufficient eye pressure control despite IOP (intraocular pressure)-lowering therapy * Diagnosis of POAG (primary open angle glaucoma) * Diagnosis of PEG (pseudoexfoliation glaucoma) * Diagnosis of PDG (pigment dispersion glaucoma) * Diagnosis of NTG (normal tension glaucoma) * Agreement of patients to participate in the study Exclusion Criteria: * Previous glaucoma surgery * Visual acuity of Nulla Lux * Poor general condition * Pregnancy * Exudative macular degeneration
Where this trial is running
Klagenfurt
- KlinikumKlagenfurt — Klagenfurt, Austria (Recruiting)
Study contacts
- Principal investigator: Yosuf El-Shabrawi — Klinikum Klagenfurt am Wörthersee
- Study coordinator: Carmen Gruzei
- Email: carmen.gruzei@kabeg.at
- Phone: +4346353826332
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.