ISRCTN14332621已完成未知
Randomised controlled non-inferiority trial of topical chlorhexidine 0.2% versus topical natamycin 5% for fungal keratitis in Nepal
ondon School of Hygiene and Tropical Medicine0 个研究点目标入组 354 人开始时间: 2019年5月15日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 354
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34896126/ (added 14/12/2021) 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32998924/ (added 17/08/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Acute microbial keratinitis characterised by:?
- •1.1 Corneal epithelial ulceration >1mm diameter ?
- •1.2 Corneal stromal infiltrate?
- •1.3 Acute inflammation: e.g. conjunctival injection, anterior chamber ?inflammatory cells, hypopyon. ?
- •2. Filamentous fungal hyphae visualised on smear microscopy and/or in vivo confocal microscopy.
- •3. Agree to be randomised to either treatment arm and able to give informed consent
- •4. Agree to be followed up at 2 days, 1 week, 2 weeks, 3 weeks, 2 months and 3 months
- •5. Adults (18 years and older)
排除标准
- •1. Unwilling to participate in trial or attend follow-up ?
- •2. Aged less than 18 years
- •3. Pregnancy: self-reported, or by urine hCG pregnancy test if uncertain. ?
- •4. Breast feeding: self-reported ?
- •5. Prior topical anti-fungal treatment
- •6. No light perception in the affected eye
- •7. Fellow eye visual acuity <6/60 ?
- •8. Acanthamoebic infection visualised by smear microscopy or IVCM
- •9. Clinical evidence of herpetic keratitis
- •10. Known allergy to study medication (including preservatives)
- •11. Previous penetrating keratoplasty in the affected eye
- •12. Bilateral corneal ulcers
- •13. Very severe ulcers warranting immediate evisceration or conjunctival flap
- •14. Fungal Endophthalmitis ?
研究者
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