Patient quality of life after different glaucoma surgeries
Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options - G-SCOPE (Glaucoma Surgery - Comparative Patient Evaluation)
This project uses the NEI-VFQ-25 vision questionnaire to see if adults who have PreserFlo MicroShunt, trabeculectomy, or non-penetrating deep sclerectomy report different quality of life after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT07303257 on ClinicalTrials.gov |
What this trial studies
This observational study will collect patient-reported visual function using the NEI-VFQ-25 before and after glaucoma surgery to compare quality-of-life outcomes across surgical techniques. Eligible adults undergoing PreserFlo MicroShunt with mitomycin C, trabeculectomy with mitomycin C, or non-penetrating deep sclerectomy with mitomycin C will be enrolled at Hôpital de La Croix Rousse in Lyon. The protocol excludes congenital glaucoma, refractory cases with multiple prior surgeries, recent ophthalmic surgery within 6 months, and severe visual comorbidities. Data will be analyzed to identify differences in patient-reported outcomes across procedures and glaucoma subtypes.
Who should consider this trial
Good fit: Adults (≥18) with an indication for glaucoma surgery who are candidates for PreserFlo MicroShunt, trabeculectomy, or non-penetrating deep sclerectomy with mitomycin C—covering open-angle, angle-closure, pseudoexfoliative, pigmentary, and certain secondary glaucomas.
Not a fit: Patients with congenital glaucoma, refractory glaucoma after multiple prior surgeries, recent ophthalmic surgery within 6 months, severe retinal comorbidities, or who cannot attend follow-up visits are unlikely to be included or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could help surgeons and patients choose glaucoma surgery that better preserves day-to-day visual function and quality of life.
How similar studies have performed: Previous studies have measured quality of life after glaucoma procedures, but direct comparisons using the same questionnaire across PreserFlo, trabeculectomy, and non-penetrating sclerectomy are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged ≥ 18 years with an indication for glaucoma surgical treatment * Eligible surgical procedures: Preserflo™ MicroShunt with mitomycin C, Trabeculectomy with mitomycin C or non-penetrating deep sclerectomy with mitomycin C * Unilateral or bilateral glaucoma, open-angle or angle-closure, at early, moderate, or advanced stages * Pseudoxexfoliative or pigmentary glaucoma * Secondary glaucoma, including: uveitic glaucoma, Steroid-induced glaucoma, traumatic glaucoma * Written informed consent obtained prior to study participation Exclusion Criteria: * Congenital glaucoma * Refractory glaucoma with a history of multiple previous surgeries * Ophthalmologic surgery within 6 months prior to inclusion * Severe visual co-morbidities (age-related macular degeneration, severe diabetic retinopathy, retinal degeneration, or similar conditions) * Expected difficulty with follow-up including poor anticipated compliance, planned travel or prolonged absence during the follow-up period * Illiteracy, inability to speak French or impaired cognitive capacity preventing adequate understanding of the study * Patients with a significant pre-existing impairment in quality of life attributable to a progressive physical illness or a neuropsychiatric disorder. * Patients under curatorship or guardianship * Pregnant women
Where this trial is running
Lyon
- Service d'Ophtalmologie, Hôpital de La Croix Rousse, Hospices Civils de Lyon — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Victor VERMOT-DESROCHES, MD
- Email: victor.vermot-desroches@chu-lyon.fr
- Phone: 426109431
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.