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临床试验/CTRI/2025/04/085354
CTRI/2025/04/085354暂停不适用

Role of Topical Insulin Therapy in Stage 2 Neurotrophic Keratopathy

Sankara Eye Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年4月28日最近更新:

试验速览

阶段
不适用
状态
暂停
入组人数
56
试验地点
1
主要终点
Complete re epithelialization of the Persistent Epithelial Defect

研究概览

简要总结

Patient with neurotrophic keratopathy (NK) will undergo routine visual acuity testing Uncorrected and best corrected visual acuity.

Slit lamp bio-microscopy examination will be done and classified into the stage of NK based on the clinical findings.

Corneal Sensations will be done by Cochet Bonnet esthesiometer.

Slit Lamp photography & dry eye imaging (keratograph) will be done subsequently.

Impression cytology sample will be taken before starting any topical therapy.

Topical therapy i.e. Topical Insulin ( Group A) & Poly Ethylene Glycol (Group B) eyedrops will be started.

Patient will be followed up after 1 week 1 month 2 months & 3 months respectively.

If the patients on topical insulin therapy does not show any improvement at one week follow up they will be shifted to conventional therapy depending on the clinical findings.

The washout period of insulin eyedrops in 1-2 days & has no local or systemic side effects as shown in the literature.

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
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Severe Dry Eye Disease Viral keratitis Chemical or mechanical trauma Chronic use of preserved Topical eyedrops Post- Ocular surgery or Neurosurgery Post irradiation Diabetes mellitus/ Keratopathy Recurrent Epithelial Erosions Neurological conditions like Vascular/ Space occupying lesions.

排除标准

  • Patients not willing for insulin therapy Pregnant & Nursing Mothers Active non-herpetic keratitis Post Keratoplasty Neurotrophic keratopathy One eyed patients.

结局指标

主要结局

Complete re epithelialization of the Persistent Epithelial Defect

时间窗: Patient will be followed up after 1 week 1 month 2 months and 3 months respectively

次要结局

  • 1 Best-corrected visual acuity(2 Days until complete re-epithelialization)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Pallavi Joshi

Sankara Eye Hospital, Bengaluru, Karnataka

研究点 (1)

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