CTRI/2022/08/045043暂停4 期
Prospective, Randomized Single-Center Post Marketing Study of using Hyper-CLâ?¢ lens to reduce treatment burden in Subjects with Bacterial Keratitis.
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
- one
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
入选标准
- •1.Subject is 18-86 years old
- •2.Subject with Bacterial keratitis in one eye only
- •3.Subject with Bacterial Keratitis infiltrate of at least 1.5 mm in diameter
- •4.Subjects with no prior antibiotic treatment or treatment up to 12 hours prior enrolment.
- •5.Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
排除标准
- •1.Perforation
- •2.Subject with elevated bleb (glaucoma shunts)
- •3.Sign of inflammation in both eyes
- •4.Severe itching suggesting viral infection or allergy reaction
- •5.Subepithelial infiltrate suggesting viral infection
- •6.Dendrite like ulcer or suspecting of Herpes keratitis
- •7.Previous penetrating keratoplasty
- •8.Pregnancy
- •9.Any infiltration suggesting other than bacterial infection e.g., parasite, fungal.
- •10.Post refractive surgery
- •11.Corneal inlays
- •12.Subject with neuropathic corneas
- •13.Subjects with Chronic autoimmune diseases
- •14.Any other condition which in the opinion of the investigator would place the patient at undue risk for participation.
- •15.Participation in another clinical study within the past 30 days
- •16.Patient requires different treatment regimen then determined by the study protocol.
研究者
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