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临床试验/NCT07146828
NCT07146828招募中不适用

Clinical Application Research of 5-Degree (0.05 D) Precision Optometry in Corneal Refractive Surgery

Affiliated Hospital of Nantong University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
1
主要终点
Postoperative spherical equivalent

研究概览

简要总结

In recent years, the incidence of myopia has been high globally and is exhibiting a rapid upward trend, with projections estimating it will reach 49.8% by 2050. Corneal refractive surgery has become a primary method for correcting myopia, demonstrating significant efficacy and favorable safety. However, studies indicate that overcorrection or undercorrection can occur following refractive surgery. Reports have shown that three months post-SMILE surgery, 20% of eyes had residual refractive errors ≥ 0.50 D, and 6% had errors ≥ 1.00 D. We hypothesize that this may be related to imprecise preoperative refraction, subsequently affecting postoperative visual quality.

Due to limitations in lens manufacturing precision, the widely used increment for sphere correction remains 0.25 D. However, this may prevent some patients from achieving their optimal corrected state. Studies have reported that 95% of individuals are sensitive to diopter changes below 0.25 D, and 44% can distinguish changes smaller than 0.125 D. Other research suggests that adjusting spherical power in 0.05 D increments yields better corrected visual acuity. Furthermore, scholars have reported that 0.05 D precision refraction can significantly improve the red-green balance test rate, enabling myopic patients to achieve better visual quality. Therefore, improving refraction precision could provide patients with superior visual outcomes.

Currently, the Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China) can perform objective and subjective refraction with 0.05 D increments for both sphere and cylinder correction, while also separately measuring higher-order aberrations (HOAs) and lower-order aberrations (LOAs). Given the scarcity of research on the outcomes of 0.05 D refraction for SMILE and FS-LASIK procedures, this study aims to evaluate visual acuity, aberrations, and refractive status in patients following SMILE and FS-LASIK surgery. The primary objective is to investigate whether preoperative 0.05 D precision refraction using the BWFOM can enhance postoperative visual quality for SMILE and FS-LASIK patients.

详细描述

This study aims to optimize the surgical parameters of corneal refractive surgery (SMILE and FS-LASIK) by utilizing 0.05 D high-precision refraction achieved through a binocular wavefront aberrometer, thereby improving patients' postoperative visual outcomes. The prospective study design involves patients scheduled for corneal refractive surgery at our hospital.

The research consists of two parts:

Part One: Performing 0.05 D precision refraction on myopic patients using the binocular wavefront aberrometer.

Part Two: Applying the obtained refraction results (in increments of 0.05 D) for refractive correction in patients undergoing SMILE and FS-LASIK surgery.

Specific procedures include:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years);
  • Age: 18 to 40 years old;
  • Optimal preoperative corrected visual acuity >= 4.8;
  • More than 2 weeks for soft contact lenses and more than 3 months for hard contact lenses before surgery
  • Patients who are willing to perform SMILE surgery

排除标准

  • Patients with history of eye surgery and trauma;
  • Patients with keratoconus tendency;
  • systemic connective tissue diseases and autoimmune diseases;
  • Patients with high blood pressure, diabetes and heart disease history;
  • Other eye disease history such as uveitis, scleritis and other eye inflammation patients;
  • Patients with scar constitution.

结局指标

主要结局

Postoperative spherical equivalent

时间窗: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively

It calculated as: SE = Sphere + ½ Cylinder

Postoperative corrected distance visualacuity

时间窗: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively

Using the standard logarithmic visual acuity chart, with units in logMAR.

Postoperative uncorrected distance visual acuity

时间窗: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively

Using the standard logarithmic visual acuity chart, with units in logMAR

spherical diopter

时间窗: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively

Spherical diopter (D) is the unit of measurement for the refractive (light-bending) power of a spherical lens (or the spherical component of a corrective lens) used to correct myopia (nearsightedness) or hyperopia (farsightedness).

cylinder diopter

时间窗: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively

The unit of measurement for the lens power required to correct astigmatism, representing the difference in refractive power between the steepest and flattest meridians (axes) of the eye or lens

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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