Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Time to re-epithelialization of neurotrophic ulcer
研究概览
简要总结
Many diseases can affect corneal nerves. Corneas that lack normal sensation are considered neurotrophic. Neurotrophic corneas are predisposed to persistent epithelial defects, recurrent erosions, and corneal ulcers. These can lead to a variety of complications, from subjective pain, discomfort, and blurry vision, to corneal perforation and endophthalmitis. Neurotrophic corneas and the persistent epithelial defects associated with them can be very difficult to treat. Non-invasive measures include topical drops (artificial tears, antibiotics, or steroids), bandage contact lens, and punctal plugs. More invasive surgical treatments include membrane grafts, tarsorrhaphy, and keratoplasty. Despite these treatments, many neurotrophic corneas still do not heal. This study aims to test the efficacy of topical insulin in the treatment of neurotrophic keratopathy.
详细描述
Purpose: To trial topical insulin drops to promote healing in neurotrophic keratitis that has been refractory to conventional management versus tarsorrhaphy.
Hypothesis: Topical insulin might promote re-epithelialization in the setting of neurotrophic keratitis (Stage 2 or 3) with persistent epithelial defect refractory to conventional treatments and be a non-inferior treatment to tarsorrhaphy.
Justification: Several experiments support the use of insulin for the promotion of corneal epithelial healing. In vitro experiments with immortalized corneal epithelial cells suggest that insulin improves epithelial cell migration. A rabbit model showed improvement in corneal hypoesthesia after topical insulin exposure. These results suggest that early hypoesthesia may be reversible, and thereby improve epithelial wound healing. Another rabbit model showed that topical insulin might alter the corneal surface by increasing the tensile strength of corneal wounds. Finally, the presence of insulin receptors on the cornea and lacrimal gland suggests that insulin may contribute to corneal wound healing.
Few case studies describe the use of topical insulin in the absence of other concurrent treatments for neurotrophic keratitis.
Objectives: Through use of topical insulin, promotion of corneal healing in cases where conventional methods have failed. These include topical antibiotics, preservative free artificial tears, and bandage contact lens for at least 2 weeks. This study will evaluate topical insulin as a salvage treatment in patients who otherwise would require tarsorrhaphy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Treatment will be randomized / assigned randomly, but neither the patients, care providers, or investigators will be masked to treatment once it is being provided.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of neurotrophic keratitis with persistent epithelial defect that has been refractory to conventional treatments for at least 2 weeks
- •18 years or older
- •Able to provide informed consent
- •Failed other conventional treatments for neurotrophic keratitis
- •Understanding and accepting of use of topical insulin alone
排除标准
- •Less than 18 years old
- •Pregnant or breastfeeding women
- •Unable to provide informed consent
- •Unable to comply with tests/follow-up
- •Lid function abnormalities (e.g., lagophthalmos, entropion, ectropion, or abnormal orbicularis function from cranial nerve 7 palsy or Bell's palsy)
- •Patients who require ongoing topical treatment (e.g. topical ganciclovir)
研究组 & 干预措施
Topical insulin
Topical insulin (Humulin R) will be compounded under sterile conditions at a local pharmacy at a concentration of 25 IU / ml in sterile balanced saline solution (0.9%). Topical insulin will be administered four times per day to the affected eye. A bottle of topical insulin can be used for 14 days. Any remaining topical insulin will be discarded as waste after 14 days.
干预措施: Insulin (Drug)
Tarsorrhaphy
Patients in this group will receive a temporary, central tarsorrhaphy and will not use additional eye drops.
干预措施: Tarsorrhaphy (Procedure)
结局指标
主要结局
Time to re-epithelialization of neurotrophic ulcer
时间窗: 3 months
Time taken for re-epithelialization of the neurotrophic ulcer which will be defined as \<0.5 mm of the remaining epithelial defect
次要结局
未报告次要终点