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NCT Number: NCT07303257

Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options

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.

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Key information

Conditions

Glaucoma Eye Closed-Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Angle-Closure Glaucoma, Open-Angle Ocular Hypertension Open-angle Glaucoma Pigmentary Glaucoma Pseudo Exfoliative Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Ophtalmologie, Hôpital de La Croix Rousse, Hospices Civils de Lyon

Lyon, 69317, France

Location status: Recruiting

Location contact

Victor VERMOT-DESROCHES, MD

CONTACT

[email protected]

426109431 ext. +33

Victor VERMOT-DESROCHES, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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.

Primary outcomes

  1. Quality of life score from the NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).

    Time frame: Pre-operative period and 6 months after intervention

    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.

Secondary outcomes

  1. Comparison of NEI-VFQ-25 scores between surgical techniques

    Time frame: 6 months postoperatively (M6)

    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.

  2. Correlation between NEI-VFQ-25 score and postoperative clinical parameters

    Time frame: Postoperative visits at Month 3 (M3)

    To assess the relationship between vision-related quality-of-life outcomes, measured by the NEI-VFQ-25 score, and objective postoperative clinical results.

  3. Correlation between NEI-VFQ-25 score and postoperative clinical parameters

    Time frame: Postoperative visits at Month 6 (M6)

    To assess the relationship between vision-related quality-of-life outcomes, measured by the NEI-VFQ-25 score, and objective postoperative clinical results.

  4. Impact of postoperative follow-up on NEI-VFQ-25 quality-of-life scores at 3 months

    Time frame: Prospective collection of postoperative follow-up data through Month 3 (M3)

    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.

  5. Impact of postoperative follow-up on NEI-VFQ-25 quality-of-life scores at 6 months

    Time frame: Prospective collection of postoperative follow-up data through Month 6 (M6)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle SZATANEK

CONTACT

[email protected]

426732724 ext. +33

Victor VERMOT-DESROCHES, MD

CONTACT

[email protected]

426109431 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: G-SCOPE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2025
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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