RBR-34d3jv2招募中1 期
Interventional clinical protocol for assessing the therapeutic efficacy of 50% Autologous Serum Eye Drops in the treatment of corneal epithelial defects in Inflammatory ocular surface diseases
niversidade Federal de São Paulo - UNIFESP/EPM0 个研究点开始时间: 2023年11月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18Y 至 80Y（—）
入选标准
- •Age 18 to 80 years. Both genders. Confirmed diagnosis of one of the following pathologies: Sjögren 's syndrome, Moderate to severe non- Sjögren's dry eye, Stevens-Johnson syndrome, Graft versus host disease, Neurotrophic keratitis, Neurotrophic pain. Presence of corneal epithelial defect without improvement after treatment with preservative-free lubricating eye drops for at least 14 days. Absence of active infection on the ocular surface. No recent use of the following medications or performance of the following procedures: anticoagulants/ anti- platelet aggregation, blood product eye drops in the last 3 months, eye surgery in the last 6 months. Does not present any of the following conditions: poorly controlled systemic disease, active infection or advanced-stage cancer, pregnancy or breastfeeding. There are no contraindications to blood donation: positive serology for HIV I and II or HTLV 1/2 or hepatitis B or hepatitis C or syphilis or Chagas disease according to Ordinance 158 of 02/04/2016 of the Ministry of Health – Brazil, anemia (hemoglobin level < 11.0 mg/dl) or thrombocytopenia (platelet level < 150 x 10 9 /L). Ability to adhere to the treatment and follow-up protocol during the study period and provide written consent for participation
排除标准
- •Diagnosis of active corneal infection. Pregnancy diagnosed after beginning the protocol. Loss of clinical follow-up. Incorrect adherence to treatment, with application of less than 70% of the expected daily dose or remaining without use for more than one full day a week. Inadequate storage and care of eye drops. Need for other interventions to treat epithelial defect
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