Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options
NCT ID: NCT07303257
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
132 participants
INTERVENTIONAL
2026-01-31
2027-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Conventional filtering techniques and MIGS (Minimally Invasive Glaucoma Surgery), including PreserFlo® MicroShunt, pursue the same objective in terms of blood pressure, but differ in terms of their post-operative profile and tolerability.
Existing studies show similar quality of life scores between filtering and MIGS surgeries. However, no direct comparison has yet been made between trabeculectomy, non-penetrating deep sclerectomy and PreserFlo® at 3 and 6 months, making it pertinent to assess their respective effects on patients' quality of life.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Preserflo
Designed to treat primary open-angle glaucoma, PRESERFLO™ MicroShunt is a tiny, soft, flexible stent that helps your eye drain excess fluid, and may help lower eye pressure and prevent further vision loss.
Preserflo
Designed to treat primary open-angle glaucoma, PRESERFLO™ MicroShunt is a tiny, soft, flexible stent that helps your eye drain excess fluid, and may help lower eye pressure and prevent further vision loss.
Trabeculectomy
Trabeculectomy is an operation which helps to drain fluid out of the eye and into a small blister (called a bleb) under the surface of the eye (the conjunctiva). The operation creates a kind of trap door for the fluid to pass through, bypassing the normal drainage channel. Drainage of aqueous is improved and this reduces intraocular pressure (IOP).
Trabeculectomy
Trabeculectomy is an operation which helps to drain fluid out of the eye and into a small blister (called a bleb) under the surface of the eye (the conjunctiva). The operation creates a kind of trap door for the fluid to pass through, bypassing the normal drainage channel. Drainage of aqueous is improved and this reduces intraocular pressure (IOP).
Non-penetrating deep sclerectomy
Non-penetrating deep sclerectomy (NPDS) is a filtering surgery where the internal wall of Schlemm's canal is excised, allowing sub-conjunctival filtration without actually entering the anterior chamber. This technique was developed to minimize the complications of trabeculectomy
Non-penetrating deep sclerectomy
Non-penetrating deep sclerectomy (NPDS) is a filtering surgery where the internal wall of Schlemm's canal is excised, allowing sub-conjunctival filtration without actually entering the anterior chamber. This technique was developed to minimize the complications of trabeculectomy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Preserflo
Designed to treat primary open-angle glaucoma, PRESERFLO™ MicroShunt is a tiny, soft, flexible stent that helps your eye drain excess fluid, and may help lower eye pressure and prevent further vision loss.
Trabeculectomy
Trabeculectomy is an operation which helps to drain fluid out of the eye and into a small blister (called a bleb) under the surface of the eye (the conjunctiva). The operation creates a kind of trap door for the fluid to pass through, bypassing the normal drainage channel. Drainage of aqueous is improved and this reduces intraocular pressure (IOP).
Non-penetrating deep sclerectomy
Non-penetrating deep sclerectomy (NPDS) is a filtering surgery where the internal wall of Schlemm's canal is excised, allowing sub-conjunctival filtration without actually entering the anterior chamber. This technique was developed to minimize the complications of trabeculectomy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Interventions: Preserflo, Trabeculectomy and non-penetrating deep sclerectomy
* Beginning, moderate and severe uni or bilateral open or closed angle glaucoma
* Pseudoxexfoliative or pigmentary glaucoma
* Patient with consent to participate in research
Exclusion Criteria
* Congenital glaucoma
* Multi-operated refractory glaucoma
* Ophthalmological surgery within 6 months of inclusion
* Severe visual co-morbidities (age-related macular degeneration, severe diabetic retinopathy, retinal degeneration, etc.)
* Difficulty in organising follow-up (foreseeable poor cooperation from the patient, planned travel or absence during follow-up)
* Patient illiterate, unable to speak French or with impaired cognitive ability
* Patients with a significant pre-existing impairment in quality of life attributable to a progressive physical pathology or neuropsychiatric disorder.
* Patients under curatorship or guardianship
* Pregnant women
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Service d'Ophtalmologie, Hôpital de La Croix Rousse, Hospices Civils de Lyon
Lyon, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Victor VERMOT-DESROCHES, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
69HCL25_0896
Identifier Type: -
Identifier Source: org_study_id