Intraoperative tissue separation and immediate visual quality following SMILE performed with VISUMAX800 using different energy and spot spacing parameters
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- UCVA ,CVA
研究概览
简要总结
Intra-operative tissue separation and immediate visual quality following
SMILE performed with VISUMAX 800 using different energy and spot spacing
parameters
A total of 30 non-consecutive patients will receive treatment with the following 6 groups of spot
separation settings, with n=5 patients ( n=10 eyes) in each group.
During and at the end of the procedure, the following parameters will be
evaluated:
-
Time taken for laser delivery ( sec)
-
Severity of the Opaque Bubble Layer( OBL) graded as <25%, <50%,
<75% and & 100%
- Ease of lenticule extraction using the “ No-dissection/ Lenticuloschisis
technique†on a grade of 1-5
4.Number of times Lenticuloschsis could not be performed or was
converted to conventional dissection technique.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •myopia or myopic astigmatism between -2 to -10D.
排除标准
- •patients with keratoconus, dry eye, PMD.
结局指标
主要结局
UCVA ,CVA
时间窗: pod1 , pod 15
MANIFEST FREFRACTION OSI MTF
时间窗: pod1 , pod 15
次要结局
- OSI MTF(post op 3 months)
研究者
Dr Sri Ganesh
CONSULTANT , NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL