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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Open-angle Glaucoma; Glaucoma Eye; Pigmentary Glaucoma; Closed-Angle Glaucoma; Pseudo Exfoliative Syndrome
• Intervention / Treatment: Other: NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).

• Study Type: Observational
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victor VERMOT-DESROCHES, MD; Phone Number: +33 426109431; Email: victor.vermot-desroches@chu-lyon.fr
• Study Contact Backup: Name: Christelle SZATANEK; Phone Number: +33 426732724; Email: christelle.szatanek@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69317
    • Recruiting
    • Service d'Ophtalmologie, Hôpital de La Croix Rousse, Hospices Civils de Lyon
    • Principal Investigator: Victor VERMOT-DESROCHES, MD
    • Contact: Victor VERMOT-DESROCHES, MD; Phone Number: +33 426109431; Email: victor.vermot-desroches@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Glaucoma patients aged ≥ 18 years, operated on using one of the following 3 types of surgery: Trabeculectomy , Deep non-perforating sclerectomy or Preserflo

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adult with open-angle/angle-closure or exfoliative or pigmentary glaucoma and a surgical indication; Adult patient with different stage of glaucoma and a surgical indication for sclerectomy + Mitomycin, PRESERFLO + Mitomycin, or trabeculectomy + Mitomycin. .

Other: NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).; The NEI-VFQ-25 questionnaire, translated into French and validated by the French National Authority for Health (HAS), is used to assess quality of life related to visual function. This questionnaire includes 25 items divided into 11 subdomains assessing vision-related functioning and 1 subdomain assessing general health status (see appendix for the detailed list). The composite score ranges from 0 to 100, with lower scores indicating a poorer perceived level of health and visual functioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score from the NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).	To evaluate, in adult patients undergoing glaucoma surgery, the change in NEI-VFQ 25 quality of life score between the pre-operative period and 6ᵉ months post-operatively, regardless of the surgical technique used.	Pre-operative period and 6 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of NEI-VFQ-25 scores between surgical techniques	Comparison of postoperative vision-related quality-of-life outcomes across the different glaucoma surgical techniques, assessed using the global NEI-VFQ-25 score at 6 months after surgery. The questionnaire yields a total score ranging from 0 to 100, with higher scores corresponding to a positive outcome. It will be self-completed by the patient, with an estimated completion time of approximately 15 minutes. No changes will be made to the department's standard postoperative follow-up protocol.	6 months postoperatively (M6)
Correlation between NEI-VFQ-25 score and postoperative clinical parameters	To assess the relationship between vision-related quality-of-life outcomes, measured by the NEI-VFQ-25 score, and objective postoperative clinical results.	Postoperative visits at Month 3 (M3)
Correlation between NEI-VFQ-25 score and postoperative clinical parameters	To assess the relationship between vision-related quality-of-life outcomes, measured by the NEI-VFQ-25 score, and objective postoperative clinical results.	Postoperative visits at Month 6 (M6)
Impact of postoperative follow-up on NEI-VFQ-25 quality-of-life scores at 3 months	To evaluate the effect of postoperative management-including adjunctive procedures, number of follow-up visits, and the occurrence of complications-on the NEI-VFQ-25 quality-of-life score in patients undergoing glaucoma surgery with a filtering bleb.	Prospective collection of postoperative follow-up data through Month 3 (M3)
Impact of postoperative follow-up on NEI-VFQ-25 quality-of-life scores at 6 months	To evaluate the effect of postoperative management-including adjunctive procedures, number of follow-up visits, and the occurrence of complications-on the NEI-VFQ-25 quality-of-life score in patients undergoing glaucoma surgery with a filtering bleb.	Prospective collection of postoperative follow-up data through Month 6 (M6)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Glaucoma; Trabeculectomy; MIGS; Sclerectomy; PreserFlo® Micro Shunt; Glaucome Surgery; NEI-VFQ 25 (National Eye Institute- Visual Function Questionnaire 25)
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Glaucoma, Angle-Closure; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures; Filtering Surgery; Trabeculectomy
• Other Study ID Numbers: 69HCL25_0896; 2025-A02669-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No