CTRI/2020/01/022842尚未招募4 期
Clinical study to evaluate the correlation of opaque bubble layer(OBL) with corneal biomechanics and densitometry in eyes undergoing SMILE for myopic correction.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- UCVA, BCVA
研究概览
简要总结
To evaluate the correlation of opaque bubble layer(OBL) with corneal biomechanics and densitometry in eyes undergoing SMILE for myopic correction. OBL can be observed in cases with too high or too low energy settings and results in increased adhesions with difficult dissection. Formation of OBL depends on biomechanical strength of cornea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •spherical equivalent up to −10 diopters (D) age of 21 years or older stable refraction for at least 1 year soft contact lens use discontinued for 1 week and rigid gas permeable lens use discontinued for 3 weeks prior to the procedure minimum corneal thickness of 480 μm residual stromal bed of at least 250 μm ability to understand and willingness to participate in all follow-up visits.
排除标准
- •evidence of residual or active ocular diseases such as herpetic keratitis, uveitis, glaucoma visually significant cataract, retinal diseases such as retinal dystrophies or diabetic retinopathy, corneal dystrophies, keratoconus history of corneal trauma or surgery, severe dry eyes (Schirmer’s 2 test value < 10 mm) use of systemic medications likely to affect wound healing (eg, corticosteroids or antimetabolites) immunocompromised state Women who are pregnant or nursing.
结局指标
主要结局
UCVA, BCVA
时间窗: Pre operative visit, post operative day 1 and day 15
次要结局
- UCVA, BCVA(Post operative day 15)
研究者
研究点 (1)
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