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临床试验/NCT02827747
NCT02827747撤回2 期

The Role of Antioxidants in Keratoconus Patients-A Randomized Controlled Trial of Oral Supplementation of Glutathione, Vitamin A, Vitamin C and Vitamin E

University of Miami2 个研究点 分布在 1 个国家开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
2 期
状态
撤回
试验地点
2
主要终点
Change in Visual Acuity Measured by Snellen Chart

研究概览

简要总结

Keratoconus is the most common primary cornea ectasia, where the cornea undergoes structural changes, leading to loss of tissue integrity and vision loss. The prevalence of Keratoconus is 1:2000 in the general population. Oxidative stress has been thought to have a major effect in the disease pathogenesis of Keratoconus. In vitro studies have shown increase in metabolites related to oxidative stress in Keratoconus disease, and that Keratoconus cells undergo increased oxidative stress and tissue damage. Animal models have shown a therapeutic effect of Vitamin C (ascorbate) in corneal wound healing. Glutathione and Vitamins A, C, and E are important antioxidants in the human body. To this date, the role of systemic antioxidant supplementation in Keratoconus patients has yet to be studied. In addition, it has yet to be established as to whether there is a correlation between serum antioxidant levels, and the severity of disease in the Keratoconus patient. The investigators propose to investigate the plasma levels of antioxidants in relation to disease severity. The investigators will also investigate the role of antioxidant supplementation-consisting of parenteral Glutathione (GSH), and Vitamins A, C and E-in delaying the disease progression in Keratoconus.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants would be without illness or condition that could make follow-up, or compliance with study medication difficult.
  • Participants may have a prior diagnosis of Keratoconus, or may be diagnosed at the initial visit.
  • Participants should not have an eye diagnosis, other than Keratoconus, that could adversely influence the visual acuity.
  • These participants must not have had prior surgical procedure to treat Keratoconus, including collagen cross-linking, Intacs ring segments, or corneal transplantation.

排除标准

  • would exclude smokers and former-smokers.

结局指标

主要结局

Change in Visual Acuity Measured by Snellen Chart

时间窗: Baseline to 24 months

次要结局

  • Plasma level of Vitamin C(Baseline to 24 months)
  • Plasma level of Glutathione (GSH)(Baseline to 24 months)
  • Change in cornea thickness as measured by video keratography(Baseline to 24 months)
  • Plasma level of Vitamin A(Baseline to 24 months)
  • Plasma level of Vitamin E(Baseline to 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ellen Koo

Assistant Professor of Ophthalmology

University of Miami

研究点 (2)

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