Refractive Transepithelial Photo-keratectomy (T-PKR) Without Addition of Mitomycin-C in High Myopia: a Retrospective Study of 69 Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Postoperative best spectacle corrected visual acuity (BSCVA) at month 3
研究概览
简要总结
The aim of this study is to evaluate the anatomical and refractive parameters following a single-step transepithelial photo-refractive keratectomy (T-PRK) without the addition of mitomycin-C for the treatment of high myopia of 6 diopters or more.
详细描述
In this retrospective study, 69 high myopic eyes of 6 diopters or more were treated in 38 patients by Trans-PRK with the SCHWIND Amaris 500E® excimer laser platform without the use of mitomycin-C. Several outcomes are measured in treated patients, such as postoperative uncorrected visual acuity (UCVA), best spectacle corrected visual acuity (BSCVA), efficacy, safety and predictability of the procedure, as well as corneal haze measurement. The patients are followed-up for 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years,
- •myopic sphere of -6 diopters or more,
- •astigmatism less than 3 diopters,
- •stable myopia not progressing for more than one year
排除标准
- •age <18 years,
- •myopic sphere less than -6 diopters,
- •astigmatism greater than 3 diopters,
- •progressive myopia (variation of more than 0.5 diopters over one year),
- •abnormal corneal topography or the presence of manifest keratoconus,
- •pre-existing eye pathology,
- •history of eye surgery,
- •active inflammatory or infectious eye disease,
- •dermatological disease or systemic connectivitis
结局指标
主要结局
Postoperative best spectacle corrected visual acuity (BSCVA) at month 3
时间窗: Month 3
Postoperative best spectacle corrected visual acuity (BSCVA) (logMAR)
Postoperative uncorrected visual acuity (UCVA) at week 1
时间窗: Week 1
Postoperative uncorrected visual acuity (UCVA) (logMAR)
Postoperative best spectacle corrected visual acuity (BSCVA) at week 1
时间窗: Week 1
Postoperative best spectacle corrected visual acuity (BSCVA) (logMAR)
Postoperative uncorrected visual acuity (UCVA) at month 1
时间窗: Month 1
Postoperative uncorrected visual acuity (UCVA) (logMAR)
Postoperative uncorrected visual acuity (UCVA) at month 3
时间窗: Month 3
Postoperative uncorrected visual acuity (UCVA) (logMAR)
Postoperative best spectacle corrected visual acuity (BSCVA) at month 1
时间窗: Month 1
Postoperative best spectacle corrected visual acuity (BSCVA) (logMAR)
次要结局
- Patient sex(Before surgery)
- Preoperative Myopia(Before surgery)
- Visual acuity safety index(3 months)
- Postoperative corneal haze measurement at month 3(Month 3)
- postoperative spherical equivalent(3 months)
- Preoperative Keratometry(Before surgery)
- Preoperative total ablation thickness(Before surgery)
- Visual acuity efficacy index(3 months)
- Predictability(3 months)
- Postoperative corneal haze measurement at month 1(Month 1)
- Postoperative corneal haze measurement at week 1(Week1)
- Postoperative refractive astigmatism at +/- 0.5D of target(3 months)
- Postoperative refractive astigmatism at +/- 1.0D of target(3 months)
- Complications(Up to 3 months)
- Patient age(Before surgery)
- Preoperative Astigmatism(Before surgery)
- Preoperative Spherical equivalence(Before surgery)
- Preoperative best spectacle corrected visual acuity(Before surgery)
- Preoperative central corneal thickness(Before surgery)
- Preoperative optical and transition zones(Before surgery)