Compare of PRP Autologous Serum and Autologous Serum by Intrastromal Injection in Different Eye Disease Conditions
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improving dry eye symptoms
研究概览
简要总结
Platelet-rich plasma (PRP) is an autologous blood product rich in proteins and growth factors. Its application has been the subject of many studies in the field of ophthalmology to stimulate tissue healing and regeneration. Due to its anatomical features (lack of blood vessels), the cornea is among the most susceptible to damage structures of the eye. Therefore, the study of the impact of various regenerative therapies (autologous blood products, serums, ) on corneal lesions is important not only scientifically, but also practically for ophthalmologist. Numerous reports described the healing effect of PRP on corneal lesions.
详细描述
Purpose The objective of the study is to compare the efficacy of 100% prp autolog serum eye drops with 100 % of intrastromal injection-rich plateles plasma autolog serum eye drops in patients with moderate to severe dry eye in keratoconus disease,corneal dystrophy,chemical burns.
Methods A total of 40 eyes were included in this prospective study. Clinical records of 20 consecutive patients with dry eye disease who had been treated with conventional autolog eye drops via intrastromal injection(conventional treatment group) and 20 consecutive patients treated with intrastromal autologous PRP eye drops i(PRP eye drops treated group) from September 2021.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dry eye diseases from other conditions( diabetes,allergy,keratoconus and others)
- •Corneal dystrophy
- •Chemical burns
- •Keratoconus
排除标准
- •Hemoglobin saturation (less than 11 mg/dl);
- •hepatopathies;
- •nephropathies;
- •coagulopathies;
- •hemoglobinopathies;
- •decompensated heart diseases;
- •infectious diseases such as Chagas, syphilis, HIV, HTLV, hepatitis B and C, and others transmissible by blood considered.
研究组 & 干预措施
PRP -plasma rich platelets group
Twenty patients (20) underwent 0.5 ml intrastromal injection of PRP plasma rich platelets (first group) every 2 weeks for one month
干预措施: PRP plasma rich platelets (Drug)
Autologous serum group
Twenty patients (20) underwent intrastromal injection of 0.5 ml of autologous serum (second group) every 2 weeks for 1 month
干预措施: Autologous serum (Drug)
结局指标
主要结局
Improving dry eye symptoms
时间窗: 12 months
hange From Baseline in Ocular Surface Staining \[
次要结局
- Improving corneal transparency(12 months)
研究者
Anita Syla Lokaj
Principal investigator Faruk Semiz
Eye Hospital Pristina Kosovo