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临床试验/NCT01809483
NCT01809483已完成3 期

Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients

Udayana University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2012年9月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
Size of corneal erosion area

研究概览

简要总结

This research aims to compare between bandage contact lens and pressure patching in reducing size of erosion area and pain scale in corneal erosion patients as well as its complications.

详细描述

This is a randomized open-label clinical trial in patients with mechanical corneal erosion. Subjects were selected to use bandage contact lens (Senofilcon A) or pressure patching. All subjects received combination of Polymyxin B, Neomycin, and Gramicidin eye drops and 0,5% Tropicamide eye drops. Evaluation was done 24 hours after treatment

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

入排标准

年龄范围
17 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • aged 17-55 years
  • onset of corneal erosion < 48 hours
  • corneal erosion due to mechanical injury
  • extensive corneal erosion > 3 mm2

排除标准

  • bilateral corneal erosion
  • corneal erosion due to chemical or thermal injury
  • history of systemic analgesic use within 1 week prior to the examination or topical analgesics within 1 hour before the examination
  • history of systemic or topical antibiotics within 1 week prior to the examination
  • other abnormalities due to trauma
  • palpebral or eyelashes position abnormalities
  • anterior segment infections
  • tear break-up time < 7 seconds in the contra lateral eye

结局指标

主要结局

Size of corneal erosion area

时间窗: 24 hour

Corneal erosion area is the multiplication of the long and short axis of corneal erosion, as measured using a caliper, with the help of fluorescein and cobalt blue slit lamp beam

次要结局

  • Pain scale(24 hour)

研究者

发起方
Udayana University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ni Nyoman Triharpini

Resident in Depatment of Ophthalmology Faculty of Medicine

Udayana University

研究点 (2)

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