NCT04552964已完成不适用
Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Global patient satisfaction
研究概览
简要总结
Glaucoma is one of the most common chronic pathologies and affects several millions patients. Among these, many have a poorly controlled glaucoma, damaging vision and leading to blindness.
One between principal reasons for poor glaucoma medication adherence is forgetfulness. To improve this issue, digital tools may benefit both ophthalmologists and patients by monitoring eye drop administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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 > 18 years old, both genders
- •Diagnosed with glaucoma, with controlled IOP (<18mmHg)
- •Currently receiving a topical glaucoma treatment
- •Receiving a multitherapy a fixed combination of dorzolamide-timolol, preservative-free.
- •Patient willing to participate in the study.
- •Patient familiar with a smartphone and its applications
排除标准
- •Patient with any eye condition in addition to glaucoma requiring expected additional treatment
- •Patient with an ongoing or known history of ocular allergy and/or uveitis and/or viral infection and or ocular infection.
- •Patient who underwent intraocular surgery within the past 3 months or scheduled to undergo intraocular surgery within the next 3 months
- •Patient with best-correct visual acuity <20/70 in the better seeing eye
- •Patient whose drop administration is performed by someone else
- •Alcohol addiction and/or heavy smoker, according to the investigator's judgement.
- •Patient inability to understand the study procedures or to give informed consent.
- •Non-compliant patient (e.g., not willing to attend a visit; way of life interfering with compliance).
- •Participation in this study at the same time as in another clinical study.
- •Patient being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee of the study sites or of the sponsor's company.
- •Patient not covered by the government health care scheme of the country in which he/she is living (if applicable).
- •Women of childbearing potential, pregnant or breastfeeding: Childbearing potential is defined as a woman who is not using a reliable method of contraception (oral contraceptive, intrauterine device, subcutaneous contraceptive implant, vaginal ring, patch) or is not surgically sterilized.
结局指标
主要结局
Global patient satisfaction
时间窗: Week 9
Global patient satisfaction (Patient satisfaction questionnaire)
次要结局
未报告次要终点
研究者
研究点 (2)
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