Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Change From Baseline in Ocular Surface Staining
研究概览
简要总结
Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.
详细描述
Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.
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
- 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
- •• Patients with symptomatic Dry eye
- •Shirmer ≤10 mm in 5 min
- •BUT ≤10 seconds
- •Corneal staining ≥3
- •Age range: 18 years and older.
- •Both genders and all ethnic groups comparable with the local community.
- •Able to understand and willing to sign a written informed consent
- •Able and willing to cooperate with the investigational plan.
- •Able and willing to complete all mandatory follow-up visits.
排除标准
- •• Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.
- •Children under
- •Pregnant women or expecting to be pregnant during the study.
- •Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
- •Concomitant use of systemic antibiotics or steroids.
- •Contact lens wear
- •Active ocular infection or allergy
- •Unable to close eyes or uncontrolled blinking
研究组 & 干预措施
Platelet -Rich Plasma (PRP)
15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90
干预措施: PRP injection (Drug)
Standard Care
15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90
干预措施: Standard care Hyaluronic acid eye drops (Drug)
结局指标
主要结局
Change From Baseline in Ocular Surface Staining
时间窗: 90 days
Surface damage to the exposed eye, assessed by staining, is graded against standard charts. According to the Oxford grade panel (Oxford Scale), the staining was graded and was classified from grade 0 to grade V (0 to 5 score). The minimum value of this scale was 0, which indicating absent surface damage, and the maximum value was 5, which meaning severe surface damages.
Change From Baseline in Shirmer Test
时间窗: 90 days
The Schirmer test I (performed without anaesthesia) was completed before any drops were instilled in the eye. Standardised Schirmer strips (Biotech Vision Care, Gandhinagar, India) were bent at the notch and placed carefully over the lower lid margin as far as possible towards the temporal angle of the lids. The patient was instructed to keep his/her eyelids closed during the test. The strips remained in place for 5 min. After 5 min, the amount of moisture in each strip was measured using a millimetre scale
次要结局
- Change From Baseline in Ocular Surface Disease Index (OSDI)(90 days)