Study Comparing a Therapeutic Lens Used Alone to a Therapeutic Lens Used in Association With an Amniotic Membrane Treated by the AMTRIX Process in Postoperative Care After Photorefractive Keratectomy (PRK)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
研究概览
简要总结
The purpose of this open controlled multicenter trial is to assess the impact of use of an amniotic membrane on post PKR recovery.
详细描述
Photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK) are two of the most widely used techniques of laser vision correction. However, one of the major disadvantages of the PRK technique is the pain experienced during 1 to 3 days after intervention.
Preliminary data on a limited number of patients tend to show a reduction of pain, tearing and discomfort in patients for whom a amniotic membrane was used under a therapeutic lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 80 years.
- •Patient undergoing bilateral PRK procedure for myopia, astigmatism or hypermetropia with technique chosen for one of the following reasons: thin cornea, irregular cornea, suspected keratoconus, practice of combat or contact sports, professional activity at risk of direct impact.
- •Patient understanding french language.
- •Patient who received the study information and provided written consent to participation in the study.
- •Patient who is a member or a beneficiary of a national health insurance plan.
排除标准
- •Pregnant woman.
- •Patient with a contraindication to PRK.
- •Diabetic patient.
- •Patient allergic to Oxybuprocaine and / or Tetracaine eye drops, to local anesthetics or to fluorescein.
- •Monophthalmic patient.
- •Person deprived of liberty by a judicial or administrative decision.
- •Adult subjected to a legal protection measure or unable to express his / her consent.
结局指标
主要结局
Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
时间窗: Day 1
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) in both eyes
次要结局
- Change of visual discomfort in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)(1 day, 2 days, 3 days, 30 to 45 days)
- Identical healing of both eyes(2 or 3 days, 30 to 45 days)
- Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)(2 days, 3 days, 30 to 45 days)
- Rate of corneal haze for each treatment(30 to 45 days)
- Better visual acuity in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)(30 to 45 days)