Follow-up Study of at Least 5 Years After a SMILE® Pro Procedure for the Correction of Hyperopia Investigating Long-term Visual Outcomes and Potential Side Effects
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Loss of more than 2 lines of CDVA
研究概览
简要总结
The planned study will investigate and evaluate refractive stability, predictability, and safety in patients who underwent SMILE® pro surgery for hyperopia with or without astigmatism at least five years ago.
This study aims to gain long-term insights into the predictability, safety, stability and side effects of the SMILE® pro procedure. It will evaluate the refractive outcome so the findings can optimize treatment nomograms and selection criteria while providing evidence of the long-term stability and predictability of the procedure.
Approximately 100 patients in the Czech Republic and Germany will participate in this study. The study was reviewed and approved by an independent research ethics committee.The study will consist of a single visit, where standard, non-invasive and painless examinations will be performed. The course of this visit will correspond to the patient's last visit five years ago as part of the clinical trial
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent the SMILE hyperopic procedure as part of the study referenced PHOBOS.
- •Patients should be able to understand the patient information and willing to sign an informed consent.
- •Patients should be willing to comply with all examinations during the visit.
排除标准
- •Patients with severe ocular or generic disorders that would prevent them from completed the visit.
- •Patients not being able to understand and give informed consent.
- •Patients who did not underwent the SMILE hyperopic procedure as part of the study referenced PHOBOS.
结局指标
主要结局
Loss of more than 2 lines of CDVA
时间窗: Baseline, 12 months, 5 years
Less than 5.0% of eyes loose more than 2 lines of CDVA at 5 years follow-up compared to the baseline visit.
Manifest refractive astigmatism greater than 2.0 D
时间窗: 5 years
Induced manifest refractive astigmatism greater than 2.0 D should occur in less than 5% of subjects at 5 years follow-up.
MRSE stability within ±1.0 D
时间窗: 12 months, 5 years
At least 95% of eyes should be stable with a change in Manifest Refractive Spherical Equivalent within ±1D between 12 months and 5 years follow-up visits.
UDVA better than 20/40
时间窗: 5 years
At least 85% of eyes intended for emmetropia achieve an UDVA of 20/40 or better at 5 years follow-up.
CDVA worse than 20/40
时间窗: 5 years
Less than 1.0% of eyes have a post-operative CDVA worse than 20/40 at 5 years follow-up.
MRSE target within ±0.5 D
时间窗: 5 years
Post-operative SE relative to the intended target should be within ±0.50D in ≥50% of eyes.
MRSE target within ±1.0 D
时间窗: 5 years
Post-operative SE relative to the intended target should be within ±1.00 D ≥75% of eyes.
次要结局
- Distribution of UDVA(Baseline, 12 months, 5 years)
- Change in CDVA(Baseline, 12 months, 5 years)
- Distribution of CDVA(Baseline, 12 months, 5 years)
- Distribution of UNVA(Baseline, 12 months, 5 years)
- Distribution of MRSE(Baseline, 12 months, 5 years)
- Change of MRSE(Baseline, 12 months, 5 years)
- Change of subjective refractive astigmatism(Baseline, 12 months, 5 years)
- Adverse events incidence(Baseline, 12 months, 5 years)
- Quality of vision(5 years)
- Contrast sensitivity changes(Baseline, 12 months, 5 years)
- Change in corneal keratometry(Baseline, 12 months, 5 years)
- Change in higher order corneal abberations(Baseline, 12 months, 5 years)
- Corneal epithelium thickness(5 years)
- Pentacam Nucleaus Staging(5 years)
研究者
Dr. Pavel Stodulka
Principal Investigator
Gemini Eye Clinic