NCT07277348尚未招募不适用
Analysis of The Outcomes of Therapeutic Photorefractive Keratectomy Combined With Prophylactic Accelerated Cross-Linking (PRK-Plus), for Treatment of Thin Suspicious Cornea: Short-Term Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- visual acuity improvement measured by LogMAR system
研究概览
简要总结
analyze the outcomes of therapeutic photorefractive keratectomy combined with prophylactic accelerated cross-linking (PRK-Plus), for treatment of thin suspicious cornea
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •CCT less than 490 microns
- •K mean more than 46 and/or K max more than
- •Astigmatism cylinder >1.5 D.
- •D value of Belin/Ambrósio Module > 1.6
- •inferior- superior asymmetry or bow-tie pattern with skewed radial axes on tangential maps and abnormal changes on (BAD).
- •Asymmetry topography between 2 eyes, even if neither eye"s topographic pattern is in itself decidedly abnormal.
- •Any significant skewed radial axis with or without inferior steepening, or one diopter or more of inferior steepening in some areas but an I-S value of ,1.4,
- •young patients with against-the-rule astigmatic patterns.
- •a PTA value 40% if calculated.
- •Abnormal Topographic Patterns
- •K2 reading of corneal back surface less than [-7].
- •D Value of CSTP > 2.5 in Belin/Ambrósio curve
- •We look at values within the central 5 mm circle; the map should be displayed in the BFTE float mode with an estimated area of 8 mm of diameter:
- •Elevation values on the front surface values > +12 μ
- •Elevation values on the back surface values >+15 μ.
- •If there is any isolated island on either front or back surfaces (in the BFS float mode)
排除标准
- •Eyes diagnosed with KC.
- •CCT less than 450 microns
结局指标
主要结局
visual acuity improvement measured by LogMAR system
时间窗: 1 year
visual acuity improvement measured by LogMAR system
次要结局
未报告次要终点
研究者
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