Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options (G-SCOPE)

Civil Hospices of Lyon

Status: Not yet enrolling

Conditions: Closed-Angle Glaucoma; Pseudo Exfoliative Syndrome; Open-angle Glaucoma; Pigmentary Glaucoma; Glaucoma Eye

Treatments: Other: NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).

Study type: Observational

Funder types: Other

Identifiers

NCT07303257

2025-A02669-40 (Other Identifier)

69HCL25_0896

Details and patient eligibility

About

Glaucoma surgery currently relies on a wide therapeutic arsenal, ranging from conventional filtering surgeries to minimally invasive glaucoma surgery (MIGS). These techniques offer distinct efficacy and safety profiles, allowing tailored management across a broad spectrum of patients. Traditionally, surgical success has been evaluated using objective clinical outcomes, such as intraocular pressure (IOP) reduction and decreased reliance on topical treatments.

However, the shift toward patient-centered medicine now requires consideration of the patient's perspective, including their subjective experience and the impact of treatment on quality of life. In this context, quality-of-life assessment has become a key component, promoting therapeutic alliance and patient adherence to care pathways. Despite its importance, few studies have evaluated and compared quality of life after glaucoma surgery using comparable surgical techniques.

Furthermore, to our knowledge, no study has specifically assessed the independent effect of postoperative follow-up on quality of life after filtering surgery with a bleb. Given that postoperative management can be prolonged and demanding, it may significantly influence patients' perceptions of surgical outcomes and overall well-being.

This study aims to address these gaps by providing a more comprehensive evaluation of the impact of glaucoma surgery beyond traditional clinical outcomes. It may represent a first step toward the development of a more appropriate assessment tool that incorporates the realities of postoperative follow-up and the specific experiences of patients undergoing filtering surgery.

The study is based on the following hypotheses: filtering glaucoma surgery preserves patients' quality of life, with a stable NEI VFQ-25 score at six months postoperatively; postoperative quality of life may be influenced by the patient's postoperative care pathway; and quality-of-life scores remain correlated with objective clinical parameters, including intraocular pressure, visual acuity, medical treatment burden, and visual field damage.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

132 participants in 1 patient group

Adult with open-angle/angle-closure or exfoliative or pigmentary glaucoma and a surgical indication

Description:

Adult patient with different stage of glaucoma and a surgical indication for sclerectomy + Mitomycin, PRESERFLO + Mitomycin, or trabeculectomy + Mitomycin. .

Treatment:

Other: NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).