NCT06393855招募中不适用
Base Curves of Bandage Contact Lenses and Their Effects on Post Transepithelial Photorefractive Keratectomy (Trans-PRK) Vision and Pain： A Prospective Randomized Clinical Trial
Dongyang People's Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年6月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Early postoperative uncorrected visual acuity
研究概览
简要总结
The objective of this study was to investigate the impact of employing bandage contact lenses with a base curve of 8.4 mm versus 8.8 mm on visual recovery following Trans-PRK in patients characterized by steep corneas and high myopia.
详细描述
Comparing two kind of bandage lenses in the contralateral eyes of the same individual following Trans-PRK may enable the derivation of reliable conclusions regarding the optimal choice for bandage lenses after Trans-PRK.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spherical equivalent refractive error between -6.00 and -8.00 D in either eye.
- •Astigmatism of no more than 2.0 D in either eye.
- •Best spectacle-corrected visual acuity (BCVA) according to the logarithm of the Minimum angle of resolution (logMAR) scale of 0 or better in both eyes.
- •Willing and able to participate in all required activities of the study.
排除标准
- •Diabetes mellitus.
- •Systemic connective tissue disease.
- •Cardiovascular disease, epilepsy.
- •Eyelid abnormalities.
- •Corneal disease.
- •A history of ocular disease.
- •Noncompliance with measurement at enrollment.
结局指标
主要结局
Early postoperative uncorrected visual acuity
时间窗: 14 days
All visual acuity measurements were performed using a standard logarithmic eye chart
次要结局
- postoperative pain score after Trans-PRK(2 weeks)
- re-epithelialization after Trans-PRK(1 week)
- spherical equivalent after Trans-PRK(1 week)
研究者
Gengmin Tong
Doctor
Dongyang People's Hospital
研究点 (1)
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