Patient quality of life after different glaucoma surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.