Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options - G-SCOPE (Glaucoma Surgery - Comparative Patient Evaluation)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Quality of life score from the NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
.
干预措施: NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25). (Other)
结局指标
主要结局
Quality of life score from the NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).
时间窗: 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.
次要结局
- Comparison of NEI-VFQ-25 scores between surgical techniques(6 months postoperatively (M6))
- Correlation between NEI-VFQ-25 score and postoperative clinical parameters(Postoperative visits at Month 3 (M3))
- Correlation between NEI-VFQ-25 score and postoperative clinical parameters(Postoperative visits at Month 6 (M6))
- Impact of postoperative follow-up on NEI-VFQ-25 quality-of-life scores at 3 months(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(Prospective collection of postoperative follow-up data through Month 6 (M6))