Hydrus Microstent as a Quality of Life Consideration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in Glaucoma Symptom Score (GSS) Score
研究概览
简要总结
The study aims to identify if Hydrus microstent implantation in patients with open angle glaucoma (OAG) at the time of cataract surgery improves quality of life for patients and explore what quality of life factors motivate patients.
详细描述
Prospective, interventional single arm study of patient-reported outcomes (PRO) via GSS with pre and post ocular surface disease assessment in subjects undergoing bilateral phaco and Hydrus implantation; Study will also explore other QOL factors that may motivate patients to accept Hydrus via Glauc-QOL36 and customized questions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Clinical diagnosis of mild to moderate open angle glaucoma as defined by with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus Microstent
- •Current treatment with one or more ocular hypotensive medication
- •Corneal thickness between 470 to 610µm
- •Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 LogMAR (20/25) postoperatively
排除标准
- •Clinical diagnosis of secondary glaucoma (traumatic, neovascular, mixed-mechanism, uveitic glaucoma)
- •corneal opacity or angle abnormalities that make visualizing the angle difficult
- •Past ocular surgery
- •History of ocular, systemic medications, or systemic diseases/co-morbidities that significantly impact on quality of life or vision (e.g. advanced macular degeneration, autoimmune diseases, mental illness/depression, uncontrolled systemic disease on polypharmacy)
- •Severe dry eye requiring secretagogues, serum eyedrops, topical corticosteroids, amniotic membrane grafts
结局指标
主要结局
Change in Glaucoma Symptom Score (GSS) Score
时间窗: 3 months
GSS is a cross-sectional study of symptoms, functional impairment, and vision-targeted health-related quality of life among persons with glaucoma, scored 0-100, with a higher score being more favorable (ie fewer adverse symptoms).
次要结局
- Number of Medication Reduction for Glaucoma(3 months)
- Ocular surface disease (OSD) assessment(3 months)
研究者
Eric Poulsen
Ophthalmologist
InSight Vision Center Medical Group, Inc