Outcomes of SMILE PRO Surgery for the Correction of Myopia With High Astigmatism
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Residual Refractive Astigmatism
研究概览
简要总结
This prospective interventional study aims to evaluate the long-term refractive and visual quality outcomes of SMILE PRO surgery in patients with myopia and high astigmatism. Eligible participants undergo small incision lenticule extraction using the VisuMax 800 femtosecond laser. Postoperative assessments include uncorrected and corrected distance visual acuity, manifest refraction, astigmatic vector analysis, contrast sensitivity, and higher-order aberrations. Participants are followed for up to 12 months to assess refractive accuracy, stability, safety, and visual quality after surgery.
详细描述
This is a single-center, prospective interventional clinical study conducted to assess the long-term refractive and visual quality outcomes of SMILE PRO surgery for the correction of myopia with high astigmatism. The study is performed at Hong Son Eye Hospital, Vietnam, following approval from the Institutional Review Board of Hanoi Medical University. All participants provide written informed consent prior to enrollment.
Patients aged 18 to 40 years with stable myopic refractive error and high astigmatism are eligible for inclusion. All eyes undergo small incision lenticule extraction using the VisuMax 800 femtosecond laser according to a standardized surgical protocol. Manifest refraction, corneal topography, and ocular imaging are performed by experienced refractive technicians using standardized measurement protocols. All patients are examined preoperatively and postoperatively by an ophthalmologist, who reviews clinical findings and surgical eligibility. All SMILE PRO procedures are performed by the same ophthalmic surgeon to minimize variability related to surgical technique.
Outcome measures include uncorrected and corrected distance visual acuity, spherical equivalent refraction, residual refractive astigmatism, and astigmatic vector analysis based on the Alpins method. Visual quality outcomes are further evaluated using contrast sensitivity testing and wavefront aberrometry to assess higher-order aberrations. Intraoperative parameters, including centration and cyclotorsion, are recorded and analyzed for their potential association with postoperative refractive outcomes.
Postoperative examinations are performed at 1 week, 1 month, 3 months, 6 months, and 12 months after surgery. The primary objective of this study is to evaluate the long-term refractive accuracy, stability, and safety of SMILE PRO surgery in eyes with high astigmatism. Secondary objectives include the assessment of preoperative and intraoperative factors influencing postoperative visual and refractive outcomes.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 40 years at the time of surgery
- •Diagnosis of myopia with high astigmatism eligible for SMILE PRO surgery
- •Stable refractive error prior to surgery
- •Adequate corneal thickness and topographic parameters suitable for SMILE PRO
- •Ability to understand the study procedures and provide written informed consent
- •Willingness and ability to attend scheduled postoperative follow-up visits
排除标准
- •Presence of corneal ectatic disorders or suspicious corneal topography
- •History of previous ocular surgery or ocular trauma
- •Active ocular disease other than refractive error
- •Systemic diseases known to affect wound healing
- •Pregnancy or breastfeeding at the time of surgery
研究组 & 干预措施
SMILE PRO surgery
Participants with myopia and high astigmatism undergoing small incision lenticule extraction using the SMILE PRO surgery.
干预措施: SMILE PRO surgery (Procedure)
结局指标
主要结局
Residual Refractive Astigmatism
时间窗: 12 months postoperatively
Residual refractive astigmatism was measured using manifest refraction and analyzed with astigmatic vector analysis based on the Alpins method.
Refractive Accuracy (Spherical Equivalent Error)
时间窗: 12 months postoperatively
Refractive accuracy was assessed using manifest refraction spherical equivalent (SEQ) after SMILE PRO surgery.
次要结局
- Refractive Stability Over Time (Spherical Equivalent)(1 week, 1 month, 3 months, 6 months, and 12 months postoperatively)
- Refractive Cylinder Over Time(1 week, 1 month, 3 months, 6 months, and 12 months postoperatively)
- Uncorrected Distance Visual Acuity (UDVA)(1 week, 1 month, 3 months, 6 months, and 12 months postoperatively)
- Corrected Distance Visual Acuity (CDVA)(1 month, 3 months, 6 months, and 12 months postoperatively)
- Surgically Induced Astigmatism (SIA)(3 months and 12 months postoperatively)
- Contrast Sensitivity(1 week, 1 month, 3 months, 6 months, and 12 months postoperatively)
- Target Induced Astigmatism (TIA)(3 months and 12 months postoperatively)
- Difference Vector (DV)(3 months and 12 months postoperatively)
- Correction Index (CI)(3 months and 12 months postoperatively)
- Angle of Error (AE)(3 months and 12 months postoperatively)
- Higher-Order Aberrations(1 week, 1 month, 3 months, 6 months, and 12 months postoperatively.)
- Lenticule Decentration(Intraoperative)
- Intraoperative Cyclotorsion(Intraoperative)