Clinical Trial of the Femtosecond Laser System VisuMax for Refractive Correction of Hyperopia by Means of Lenticule Extraction
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Safety of corrected distance visual acuity (change in corrected distance visual acuity)
研究概览
简要总结
This is a feasibility and clinical evaluation study of the VisuMax femtosecond laser for refractive correction of hyperopia using the small incision lenticule extraction (ReLEx smile) method.
In ReLEx® the VisuMax femtosecond laser creates two interfaces that define a refractive lenticule of stromal tissue. In ReLEx® FLEx, the upper interface is converted into a LASIK flap by the creation of a sidecut. The LASIK flap is lifted and the lenticule can be removed to correct the refractive error by tissue subtraction. In ReLEx® smile, the lenticule is dissected and removed through a small 2-3mm incision without the need to create a whole flap.
The aims are i) to optimize the VisuMax settings for lenticule separation ii) to optimize the lenticule geometry iii) to assess the safety, efficacy and stability of the treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •older than 21 years of age,
- •maximum hyperopic meridian between +1.00D and +7.00D
- •astigmatism up to 6D
- •20/200 or worse in the eye(s) being treated for Phase I
- •Between 20/200 and 20/100 in the eye(s) being treated for Phase II
- •Between 20/40 and 20/60 in the eye(s) being treated for Phase III
- •20/25 or better for Phase IV
- •total uncut stromal thickness of more than 300 µm
- •no previous refractive surgery,
- •no ocular disease,
- •normal corneal topography,
- •contact lens wearers have to stop wearing hard contact lenses at least 4 weeks and soft contact lenses 2 weeks prior to pre-examination,
- •willing to attend follow-up examinations within the scope of the clinical investigation,
- •able and willing to sign the informed consent
排除标准
- •patients who are not being able to lie flat in a horizontal position,
- •patients who are not being able to understand and give informed consent,
- •pregnant or nursing women (or women who are planning to became pregnant during the clinical investigation),
- •diagnosis of an autoimmune disease (e.g. AIDS), connective tissue disease or diabetes,
- •treatment with medications such as steroids or immune-suppressants,
- •herpes simplex or herpes zoster keratitis,
- •all standard medical exclusion criteria for LASIK
研究组 & 干预措施
Small incision lenticule extraction
Small incision lenticule extraction (SMILE) is a form of corneal laser refractive surgery performed using a femtosecond laser
干预措施: Small incision lenticule extraction (Procedure)
Small incision lenticule extraction
Small incision lenticule extraction (SMILE) is a form of corneal laser refractive surgery performed using a femtosecond laser
干预措施: ReLEx® (SMILE) (Device)
结局指标
主要结局
Safety of corrected distance visual acuity (change in corrected distance visual acuity)
时间窗: 1 year
Assess the change in corrected distance visual acuity (CDVA) before and after the SMILE procedure.
Efficacy of uncorrected distance visual acuity (uncorrected distance visual acuity achieved after the SMILE procedure relative to the preoperative CDVA)
时间窗: 1 year
Measure the uncorrected distance visual acuity achieved after the SMILE procedure relative to the preoperative CDVA for all eyes where the intended target refraction was emmetropia.
Predictability of refractive outcome ( change in manifest refractive error)
时间窗: 1 year
Measure the change in manifest refractive error (sphere, cylinder, spherical equivalent) after the SMILE procedure and analyze the predictability relative to the intended target refraction as well as the refractive stability over the 1 year follow-up period
次要结局
- Optical zone centration (Measure the achieved centration of the optical zone)(1 year)
- Optical zone diameter(1 year)