Prospective Clinical Study to Evaluate the Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Absolute refractive predictability
研究概览
简要总结
This is a prospective, comparative, randomized, controlled, single-blind, single-surgeon, single-center PMCF clinical study whereby participants undergoing refractive surgery for correction of ametropia will receive a transepithelial PRK (tPRK) and conventional PRK treatment in the contralateral eye. To avoid bias in the clinical outcomes, the two PRK treatment options are randomized to the eyes of the patients based on ocular dominance. In addition, a 1:1 randomization is applied within the tPRK group to eyes with and without end-treatment laser polishing.
Both procedures, standard PRK and tPRK, are performed in a one-step procedure. The main difference between the procedures is, that in conventional PRK, the epithelium will be removed using alcohol, whereas in tPRK procedures, the epithelium will be removed by laser ablation.
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
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ametropia
- •Myopic subjects with refractive spherical equivalent (MRSE) between -1.5D and -9.0D
- •Hyperopic subjects with refractive spherical equivalent (MRSE) between +1.5D and +5.25D
- •Signed informed consent form
排除标准
- •Ocular comorbidity
- •Subject taking systemic medications likely to affect wound healing such as corticosteroids or antimetabolites.
- •Subjects who are known to be pregnant, lactating, or who plans to become pregnant over the medications used for standard tPRK.
- •Subjects participating in any other ophthalmic clinical trial during this clinical study.
- •Subjects with cognitive impairments or other vulnerable persons
结局指标
主要结局
Absolute refractive predictability
时间窗: 3 months follow up
Absolute refractive predictability is the absolute difference between intended and achieved Manifest Refraction Spherical Equivalent (MRSE) between eyes
次要结局
- Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions(3 months follow up)
- Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions(3 months follow up)
- Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions(3 months follow up)
- Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions(3 months follow up)
- Halo Photic phenomena(3 months follow up)
- Glare Photic phenomena(3 months follow up)
- Monocular Contrast Sensitivity(3 months follow up)
- Visual perception scale(3 months follow up)
- Corneal pain(3 months follow up)