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临床试验/NCT01031888
NCT01031888已完成1 期

Phase 1 Study of Topical Autologous Insulin Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
18
试验地点
1
主要终点
Duration for the corneal surface to completely re-epithelize

研究概览

简要总结

Topical insulin application has been proved recently to increase corneal reepithelization rate over diabetic animals. However, its effectiveness on corneal epithelial wound healing in patients who received pars planar vitrectomy (PPV) for diabetic retinopathy and penetrating keratoplasty has not been reported. In this study, we plan to perform a prospective randomized study to determine the effectiveness of topical insulin as a primary treatment for corneal epithelial defect in patients undergoing vitrectomy for diabetic retinopathy and penetrating keratoplasty. All patients enrolled in this study have received corneal epithelial debridement at the end of the ocular surgeries, namely PPV for diabetic retinopathy and penetrating keratoplasty. The patients were randomized into two treatment groups. In the control group, the patients receive conventional postoperative eye drops including topical steroid, antibiotic and mydriatics. In the experimental group, the patients receive topical insulin eye drops in addition to conventional postoperative eye drops. The duration for the corneal surface to completely re-epithelize, the incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, corneal melting, sterile corneal ulcer, corneal neovascularization), and the incidence of recurrent epithelial break down after initial epithelization will be compared between these two groups. Patients undergoing PPV for diabetic retinopathy and penetrating keratoplasty will be compared separately.

详细描述

Purpose: To evaluate the treatment effects of topical insulin eye drops for promoting corneal epithelium wound healing in patients receiving pars planar vitrectomy (PPV) for diabetic retinopathy and penetrating keratoplasty.

Background: During PPV for diabetic retinopathy retinopathy and penetrating keratoplasty, removal of the edematous corneal epithelial layer was usually required in order to obtain a better surgical view1 or enhance the postoperative epithelial wound healing process. However, delayed epithelial healing was frequently found in these patients after surgeries. In addition, corneal epithelial defect is also frequent found in diabetic patients after PPV even corneal epithelial debridement is not performed during the operation. Topical insulin application has been known to increase corneal reepithelization rate over diabetic animals, has is known to have no influence on systemic glucose level in humans and animals. In this study, we plan to perform a prospective randomized study to determine the effectiveness of topical insulin eye drops as a primary treatment in corneal epithelial defect following vitrectomy in diabetic patients and penetrating keratoplasty.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Diabetic patients with proliferative retinopathy receiving PPV
  • Patients qualified for penetrating keratoplasty
  • DM control blood sugar AC < 200mg/dl
  • no limbus defect
  • no glaucoma before and after surgery
  • Patients willing to receive surgery, blood drawl and OPD follow up
  • no previous corneal epithelial defect or disease

排除标准

  • Limbus defect
  • postsurgical use of other eye drops
  • incomplete eyelid closure
  • unable to be followed up postoperatively
  • poor visual acuity or poor prognostic visual acuity
  • corneoneuropathy
  • severe dry eye syndrome
  • receive eye surgery within one month after the previous eye surgery

研究组 & 干预措施

1

Active Comparator

Corneal epithelial wound healing in patients who received pars planar vitrectomy (PPV) for diabetic retinopathy receiving topical insulin eye drops in addition to conventional postoperative eye drops

干预措施: Topical insulin eye drops (Drug)

2

Active Comparator

Corneal epithelial wound healing in patients who received pars planar vitrectomy (PPV) for penetrating keratoplasty receiving topical insulin eye drops in addition to conventional postoperative eye drops

干预措施: Topical insulin eye drops (Drug)

3

Placebo Comparator

Corneal epithelial wound healing in patients who received pars planar vitrectomy (PPV) for diabetic retinopathy treated with conventional postoperative eye drops

干预措施: Conventional postoperative eye drops (Drug)

4

Placebo Comparator

corneal epithelial wound healing in patients who received pars planar vitrectomy (PPV) for penetrating keratoplasty receiving conventional postoperative eye drops

干预措施: Conventional postoperative eye drops (Drug)

结局指标

主要结局

Duration for the corneal surface to completely re-epithelize

时间窗: 1week, 2 weeks, 1 month, 2 month, 3 month, 6 month

次要结局

  • Incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, corneal melting, sterile corneal ulcer, corneal neovascularization)(1 week, 2 weeks, 1 month, 2 month, 3 month, 6 month)
  • Incidence of recurrent epithelial break down after initial epithelization(1 week, 2 weeks, 1 month, 2 month, 3 month, 6 month)

研究者

申办方类型
Other

研究点 (1)

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