TCTR20240723010尚未招募2 期
Phase II/III open-label randomized-controlled trial to evaluate the safety and efficacy of Fibrin sealant Thai Red Cross Society compared with commercially available fibrin sealant (TISSEEL) in pterygium volunteer
Health Systems Research Institute (HSRI)0 个研究点目标入组 44 人开始时间: 2024年7月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
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
- 18 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •1.Primary pterygium grade T1 or T2 with indication for surgical excision
- •Classification of Pterygium Morphology:
- •Grade T1 = Atrophic pterygium, episcleral vessels unobscured
- •Grade T2 = Intermediate pterygium, episcleral vessels partially obscured
- •Grade T3 = Fleshy pterygium, episcleral vessels totally obscured
- •2. Voluntary informed consent obtained from the patient who is available to come on follow-up visits as indicated in protocol
排除标准
- •1. Currently on topical medication except artificial tears or lubricant gel
- •2. Diagnosed with ocular surface disease except pterygium, meibomian gland dysfunction, and dry eyes
- •3. Contraindicated for pterygium surgery with conjunctival autograft such as glaucoma or pseudopterygium
- •4. Previous conjunctival surgery such as previous pterygium surgery, strabismus surgery or conjunctival mass excision
- •5. Indicated to combine pterygium surgery with other procedure such as cataract surgery
- •6. Indicated to combine pterygium surgery with mitomycin-C
- •7. Pregnancy
- •8. Preexisting positive serologic test (HBsAg, anti-HCV, anti-HIV or anti-TP)
研究者
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