Correlation Between ICL Vault and Preoperative Refraction ( Spherical Equivalent) and Anterior Segment Parameters Measured by Optical Biometry and Scheimpflug Imaging
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- ICL vault size
研究概览
简要总结
This prospective non-comparative interventional study aims to analyse the pre-operative factors affecting the range of optimal ICL vaulting. the main question is what is the correlation between age, gender, spherical equivalent, white to white, anterior chamber volume and depth and postoperative vault? participants will do preoperative investigations ( specular microscopy, pentacam and biometry ) then refractive surgery (ICL implantation) followed by follow-up visits to assess the post-operative ICL vault and visual outcome.
详细描述
Procedure: Refractive error correction by implantable contact lens ( ICL) will be preceded by a Preoperative assessment of the patient's anterior segment using specular Microscopy, pentacam and biometry and full ophthalmic examination.
Post-operatively, visual acuity evaluation, intraocular pressure, and anterior and posterior segments examination using a slit lamp will be done on days 1 and 3 and then repeated after 1 month and 6 months Assessment of ICL vault measurement using pentacam scheimpflug imaging after 1 and 6 months will be done then a correlation between the ICL vault and the patient's refractive error and preoperative anterior segments parameters will be evaluated
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age:21 - 45 years old.
- •High Myopia or Myopic astigmatism.
- •Patients with stable preoperative refraction for the previous 12 months.
- •Aqueous depth (ACD internal) = 2.8 mm or greater from the endothelial side using pentacam.
- •Patients who are not fit for LASIK.
- •No previous intraocular surgeries.
排除标准
- •Patients with endothelial cell count < 2800 cells /mm2
- •Patients with corneal opacities
- •Patients with preoperative glaucoma, cataract, and retinal disease.
- •Patients with any systemic diseases especially collagen diseases.
结局指标
主要结局
ICL vault size
时间窗: 1 month
assessment of ICL vault by scheimpflug image
ICL Vault size
时间窗: 6 months
assessment of ICL vault by scheimpflug image
Post Operative UCVA and BCVA
时间窗: 6 months
assessment of Post Operative visual acuity
Post Operative IOP
时间窗: 6 month
assessment of post operative intraocular pressure
次要结局
未报告次要终点
研究者
Nermine Said Aly Madkour
ophthalmology consultant
Kasr El Aini Hospital