Actively Recruiting
Clinical Application Research of 5-Degree (0.05 D) Precision Optometry in Corneal Refractive Surgery
Led by Affiliated Hospital of Nantong University · Updated on 2025-08-28
600
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Application Research of 5-Degree (0.05 D) Precision Optometry in Corneal Refractive Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years)
- Age between 18 and 40 years old
- Optimal preoperative corrected visual acuity >= 4.8
- Has stopped wearing soft contact lenses for more than 2 weeks and hard contact lenses for more than 3 months before surgery
- Willing to undergo SMILE surgery
You will not qualify if you...
- History of eye surgery or trauma
- Presence or tendency of keratoconus
- Presence of systemic connective tissue diseases or autoimmune diseases
- History of high blood pressure, diabetes, or heart disease
- History of other eye diseases such as uveitis, scleritis, or other eye inflammations
- Having a scar constitution
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Binocular Wavefront Optometry Machine
Nantong, Jiangsu, China, 226001
Actively Recruiting
Research Team
Y
Ying Yu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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