Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Days until closure of the corneal wound
研究概览
简要总结
Purpose: To evaluate the clinical outcome of patients with refractory Neurotrophic Keratopathy (NK) in stages 2 and 3 treated with topical insulin.
Methods: A retrospective, observational analysis of eyes with NK in stages 2 and 3 refractory to standard medical and/or surgical treatment which were treated with topical insulin. Topical insulin (1 unit per mL) was applied 4 times a day; treatment was continued until persistent epithelial defect (PED) or ulcer resolved and then tapered accordingly. The primary outcome of the study was the complete resolution of the PED or ulcer. Best-corrected visual acuity (BCVA), days until complete resolution as well as anterior segment photographs were obtained.
详细描述
Study type
Retrospective, observational, single-center study at the Department of Ophthalmology of Centro Hospitalar Vila Nova de Gaia e Espinho, EPE.
Data was obtained from patients' medical records and anterior segment photographs from October 1, 2018 to November 1, 2020.
Each participant and/or relative was given a detailed explanation and a written informed consent regarding possible alternatives, risks and benefits of off-label use of topical insulin drops. This study was approved by the board of Centro Hospitalar de Vila Nova de Gaia e Espinho (UIEC-2020-981914339595fa024c567ec5). This study complied with the tenets of the Declaration of Helsinki.
Patient selection
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Days until closure of the corneal wound
时间窗: Time until complete resolution of corneal wound, assessed up to 8 weeks
Days
次要结局
- Best-corrected Visual Acuity improvement(Before and after treatment completion, assessed up to 8 weeks)
研究者
Dr. Ricardo Machado Soares, MD
Principal Investigator
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.