Fungal ulcer Augmented treatment with Natamycin and Cyclosporine Trial – Pilot study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity at 3 months between the placebo and intervention groups
研究概览
简要总结
Corneal ulcers caused by fungus are associated with worse visual outcomes compared to other causes of infectious keratitis. Incidence of fungal corneal account for 35-44% of corneal ulcers in South India. “Successful" treatment is not always associated with a good visual outcome as the scar that accompanies resolution of fungal keratitis leaves many eyes blind. The host inflammatory response is required for immune protection, but can also lead to pathological tissue damage if not controlled. Topical steroids, can be beneficial as adjunctive therapy with bacterial keratitis, are not used with fungal keratitis as they promote fungal growth and worsen the infection. Topical cyclosporine demonstrates anti-fungal activity in vitro and modify inflammation via a different mechanism than topical steroids. The main objective of this study is to decrease vision loss from fungal ulcers by studying and predicting which cases of fungal keratitis may benefit from adjuvant topical cyclosporine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Smear or culture positive for fungal keratitis, of any size and Visual acuity of worse than 6/12 and better than 3/60.
排除标准
- •Impending perforation/perforation/endophthalmitis Evidence of acanthamoeba by stain/herpetic keratitis by history or exam/bacterial mixed infection History of corneal scar in the affected eye and best corrected visual acuity worse than 6/60 in other eye Bilateral ulcers Previous penetrating keratoplasty Known allergy to study medications (cyclosporine or preservative) Previous history of topical steroid/native medication use.
结局指标
主要结局
Best corrected visual acuity at 3 months between the placebo and intervention groups
时间窗: Best corrected visual acuity at 3 months between the placebo and intervention groups
次要结局
- Scar size(3 months)
- Corneal perforation and need for therapeutic keratoplasty(3 months)
研究者
Josephine Christy
Aravind Eye Hospital, Pondicherry, India