GLAUCOMA 1, OPEN ANGLE, D (Disorder)
Conditions
Keywords
open angle glaucoma
Brief summary
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 PRESERFLO™ MicroShunt is at least as effective as the trabeculectomy in reducing IOP after surgery. The main questions it aims to answer are: Does the PRESERFLO™ 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 PRESERFLO™ 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.
Interventions
The PRESERFLO™ 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.
PROCEDURETrabeculectomy with MMC
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
Sponsors
Medical University of Bialystok
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-\>21 years of age * An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEXG) * Inadequately controlled on maximum tolerated medical therapy * Mean Deviation (MD) \</= -3 * Intraocular pressure of 14-28 mmHg * Endothelial Cell Count ≥1000 cells/mm2
Exclusion criteria
* An established diagnosis of: Closed-angle glaucoma or Secondary open-angle glaucoma (besides PDG and PEX) * Lens status: Aphakic patients or Anterior chamber intraocular lens * Previous procedures: Glaucoma shunt/valve/ surgery or cyclodestructive procedure, Selective laser trabeculoplasty within the past 3 months, Incisional ophthalmic surgery involving the conjunctiva within the past 3 months, Clear corneal cataract or trabecular meshwork surgery conducted within the past 6 months * Presence of intraocular silicone oil * No light perception vision * Current corticosteroid use (ocular or oral) * Conjunctival pathologies (e.g., pterygium) * Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) * Vitreous present in the anterior chamber * Active iris neovascularization or neovascularization of the iris within 6 months of the surgical date * Unwillingness or inability to give consent, accept randomization or return for and participate in scheduled protocol visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure | 12 months | Intraocular pressure will be assesed with Goldmann Applanation tonometer at the same time of a day between 8.00-10.00 am. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of medications | 12 months | — |
| surgical success | 12 months | 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). |
| complications | 12 months | — |
Countries
Poland
Contacts
CONTACTJoanna Konopinska
Outcome results
None listed