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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Quality of life score from the NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25). [Срок оценки: Pre-operative period and 6 months after intervention]

Вторичные конечные точки (5)

• Comparison of NEI-VFQ-25 scores between surgical techniques [Срок оценки: 6 months postoperatively (M6)]
• Correlation between NEI-VFQ-25 score and postoperative clinical parameters [Срок оценки: Postoperative visits at Month 3 (M3)]
• Correlation between NEI-VFQ-25 score and postoperative clinical parameters [Срок оценки: Postoperative visits at Month 6 (M6)]
• Impact of postoperative follow-up on NEI-VFQ-25 quality-of-life scores at 3 months [Срок оценки: 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 [Срок оценки: Prospective collection of postoperative follow-up data through Month 6 (M6)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

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

Идентификаторы

NCT: NCT07303257 · 69HCL25_0896 · 2025-A02669-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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