Use of topical Insulin for management of refractory persistent epithelial defects (PED)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete re-epithelisation (percent of people)
研究概览
简要总结
Persistent corneal epithelial defects (PEDs) are difficult to treat and often refractory to conventional treatment. Insulin has been shown to play a role in the epithelial cell proliferation, restoring DNA synthesis and wound healing in the human eyes by acting on the Insulin like growth factor (IGF) receptors.
Advantages of topical Insulin drops are excellent tolerance, easy availability, cost-effectiveness, non-invasive, lower immune reaction, lower infection rate, longer shelf life and easier handling as compared to the other novel modalities of treatment. This study aims to evaluate the efficacy of topical Insulin in the treatment persistent corneal epithelial defects refractory to usual medical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with persistent corneal epithelial defect (due to following etiologies: neurotrophic keratitis, chemical or thermal burns, neuroparalytic, multiple sclerosis, diabetes mellitus, immune mediated, post corneal transplants) of more than 2 weeks duration not responding to conventional treatment 2.Age group more than 18 years.
- •3.Diabetics and non- Diabetics both.
排除标准
- •1.Bacterial or fungal infection on corneal swab 2.Patients with immunosuppressed status eg.
- •HIV, Malignancies 3.Unable to comply with tests/follow-up 4.Lid abnormalities (e.g. entropion, ectropion, trichiasis, etc) 5.Pregnant or breastfeeding women.
结局指标
主要结局
Complete re-epithelisation (percent of people)
时间窗: 1 month
次要结局
- Change in best corrected visual acuity (BCVA)(1 month)
- If complete re-epithelisation not achieved, size of corneal epithelial defect(1 month)
- Re-epithelialisation time (absence of fluorescein stain) and rate (initial area of PEDmm2/days till re-epithelisation)(1 month)
研究者
Parul Jain
Guru Nanak Eye Center, Maulana Azad Medical College