Visual and Refractive outcomes of a new Presbyopia correcting Implantable Collamer Lens in correcting Refractive Errors
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Following tests will be performed
研究概览
简要总结
All patients aged between 45 and 55 years will undergo implantation of a new ICL which is correcting both myopia or hypermetropia along with presbyopia. these patients are evaluated post operatively on day1, day15 and 3 months with the tests that are mentioned above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 45.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Myopic patients more than -4D and hyperopic patients berween +1 to +10D Best corrected Visual acuityof 20/40 or better No evidence of irregular astigmatism on corneal tomography Anterior chamber depth more than 2.8mm Endothelial cell count more than 2000 cells/mm2.
排除标准
- •Astigmatism more than 0.5D Progressive or unstable myopia and/or stigmatism.
- •Clinical or topographic evidence of keratoconus Previous ocular surgery.
- •Dysfunctional lens syndrome, any evidence of cataract.
- •Any other active or recurrent ocular diseases.
- •Age related degenerations, any retinal pathology.
- •Corneal scars, opacities, degenarations, Glaucoma, Uncooperative patient.
结局指标
主要结局
Following tests will be performed
时间窗: On post-operative day 1, 2 weeks and 12 weeks
1.Uncorrected and Corrected distance visual acuity
时间窗: On post-operative day 1, 2 weeks and 12 weeks
2.Uncorrected and Corrected Intermediate visual acuity at 40, 60, 80cm
时间窗: On post-operative day 1, 2 weeks and 12 weeks
3.Uncorrected and Corrected near visual acuity
时间窗: On post-operative day 1, 2 weeks and 12 weeks
4.Subjective Refraction
时间窗: On post-operative day 1, 2 weeks and 12 weeks
5.Intraocular pressure
时间窗: On post-operative day 1, 2 weeks and 12 weeks
6.Slit lamp examination for clinical vault and angle
时间窗: On post-operative day 1, 2 weeks and 12 weeks
7.Vault angle and height measurements using MS-39
时间窗: On post-operative day 1, 2 weeks and 12 weeks
8.Binocular visual acuity for near and distance
时间窗: On post-operative day 1, 2 weeks and 12 weeks
9. SRD
时间窗: On post-operative day 1, 2 weeks and 12 weeks
10. HDA
时间窗: On post-operative day 1, 2 weeks and 12 weeks
11. iTrace
时间窗: On post-operative day 1, 2 weeks and 12 weeks
12. Defocus curve
时间窗: On post-operative day 1, 2 weeks and 12 weeks
13. FACT
时间窗: On post-operative day 1, 2 weeks and 12 weeks
14. Dysphotopsia questionnaire
时间窗: On post-operative day 1, 2 weeks and 12 weeks
次要结局
- Following test will be performed(1. slit lamp photographs)
研究者
Dr Supriya Sriganesh
Nethradhama Super Speciality Eye Hospital