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| ID | Type | Description | Link |
|---|---|---|---|
| 1776 | Other Identifier | Medical University of Bialystok |
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The goal of this randomized controlled clinical trial is to learn whether two minimally invasive bleb-forming glaucoma implants can effectively treat adult patients with open-angle glaucoma who require surgical lowering of intraocular pressure (IOP). Specifically, the study evaluates whether the PRESERFLOâ„¢ MicroShunt is at least as effective as the trabeculectomy in reducing IOP after surgery.
The main questions it aims to answer are:
Does the PRESERFLOâ„¢ MicroShunt provide IOP reduction at 12 months that is non-inferior to trabeculectomy? How do these two surgeries compare over 12 months with respect to medication reduction, need for additional glaucoma procedures, complications, and preservation of visual function and ocular structures?
Participants will:
Be randomly assigned (1:1) to receive either the trabeculectomy or the PRESERFLOâ„¢ MicroShunt during a single glaucoma surgery.
Attend scheduled follow-up visits over 12 months for eye-pressure measurements, vision testing, visual-field testing, OCT imaging, endothelial-cell counts, and safety assessments.
Receive standard postoperative care and report any complications or additional treatments during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedure: trabeculectomy | Active Comparator | trabeculectomy with mitomycin C |
|
| PreserFlo Microshunt | Experimental | Preserflo MicroShunt implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preserflo MicroShunt Implantation | Device | The PRESERFLOâ„¢ MicroShunt is a SIBS-polymer microshunt. This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | Intraocular pressure will be assesed with Goldmann Applanation tonometer at the same time of a day between 8.00-10.00 am. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of medications | 12 months | |
| surgical success | Complete surgical success is defined as achieving an IOP of ≤ 18 mmHg and a reduction of ≥20% from baseline, without the need for additional antiglaucoma medication. Qualified success was defined as achieving an IOP ≤ 18 mmHg and a reduction of ≥20% from baseline, while concurrently using intraocular pressure-lowering medications (maximum 2). |
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Inclusion Criteria:
->21 years of age
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joanna Konopinska | Contact | +48857468372 | joanna.konopinska@umb.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Bialystok | Recruiting | Bialystok | Polska | 15-089 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39394492 | Background | Governatori L, Oliverio L, Mermoud A, Scampoli A, Sarati F, Carradori A, Catalani R, Monaco C, Caporossi T, Rizzo S. PreserFlo MicroShunt versus trabeculectomy: an updated meta-analysis and systematic review. Graefes Arch Clin Exp Ophthalmol. 2025 Apr;263(4):885-899. doi: 10.1007/s00417-024-06649-w. Epub 2024 Oct 12. | |
| 37109334 |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Trabeculectomy with MMC | Procedure | Trabeculectomy (TE) has been steadily improved over the last decades and remains globally accepted as the therapeutic gold standard, great efforts are being made to develop alternative surgical options. This is mainly due to the high rate of complications after TE, including hypotony with choroidal detachment, a flat anterior chamber, or hyphema, as well as a complex postoperative follow-up |
|
| 12 months |
| complications | 12 months |
| Nobl M, Grun C, Kassumeh S, Priglinger S, Mackert MJ. One-Year Outcomes of PreserfloTM MicroShunt Implantation versus Trabeculectomy for Pseudoexfoliation Glaucoma. J Clin Med. 2023 Apr 20;12(8):3000. doi: 10.3390/jcm12083000. |