Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- National Eye Index Scores
研究概览
简要总结
Introduction: Glaucoma is the second leading cause of blindness globally. Most anti-hypertensive drops contain preservatives harmful to the corneal epithelium, with up to 78% of treated patients reporting dry eye symptoms. Autologous serum eye drops (ASED), contains essential growth factors and nutrients which may promote corneal and conjunctival integrity, offering benefits over traditional treatments. This study investigates the efficacy of 20% ASED over placebo in the treatment of corneal epitheliopathies in patients with glaucoma treated with antihypertensive drops.
Methods: The present study is a triple-blinded, randomized controlled trial that anticipates to enroll 25 patients (50 eyes) with bilateral corneal epitheliopathy secondary to antihypertensive glaucoma treatments. Patients will receive autologous serum eye drops in one eye and placebo in the contralateral eye for two months, in addition to standard artificial tears treatment.
The primary outcome is the comparison of National Eye Institute (NEI) scores between autologous serum drops and placebo-treated eyes at two months. Secondary outcomes include Schirmer's test scores, visual acuity, tear break-up time (TBUT), Ocular Surface Disease Index (OSDI) scores, intraocular pressure, and complication rates.
The study aims to analyze the effectiveness of autologous serum eye drops in treating corneal epitheliopathies in glaucoma patients, potentially offering a new therapeutic avenue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with glaucoma who developed corneal epitheliopathy secondary to antihypertensive drops;
- •Epitheliopathy refractory to conventional therapies (Artificial Tears, ointment, topical cyclosporine or punctal plug, etc.);
- •National Eye Institute score of 3 or more for both eyes;
- •Adults aged 18 to 90 years inclusively.
排除标准
- •Corneal epitheliopathy of other origin (ie. mechanical, neurotrophic, toxic, post-infectious, limbal stem cell deficiency);
- •Glaucoma surgery within the last six (6) months;
- •Previous corneal surgery;
- •Active autoimmune disease;
- •Frequent contact lense wear;
- •Pregnant or actively breast-feeding;
- •Known systemic infection with HIV, hepatitis B and C or syphilis;
- •Known severe anemia (Hb < 100 g/L);
- •Inability to give informed consent
研究组 & 干预措施
20% Autologous serum eye drops + Artificial tear drops
干预措施: 20% ASED + AT (Biological)
0.9% NS eye drops + Artificial tear drops
干预措施: 0.9% NS + AT (Drug)
结局指标
主要结局
National Eye Index Scores
时间窗: 2 months
Compare NEI scores at 2 months between eyes treated with ASED 20% versus placebo in patients with corneal epitheliopathy secondary to antihypertensive glaucoma treatments.
次要结局
- Ocular Surface Disease Index(2 months)
- Intraocular Pressure(2 months)
- Complication rates(2 months)
- Visual Acuity(2 months)
- Tear Break Up Time(2 months)
- Schirmer Test(2 months)