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

RecruitingNAAges 18 Years - 40 YearsAllAffiliated Hospital of Nantong University
NCT07146828 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years); 2. Age: 18 to 40 years old; 3. Optimal preoperative corrected visual acuity \>= 4.8; 4. More than 2 weeks for soft contact lenses and more than 3 months for hard contact lenses before surgery 5. Patients who are willing to perform SMILE surgery Exclusion Criteria: 1. Patients with history of eye surgery and trauma; 2. Patients with keratoconus tendency; 3. systemic connective tissue diseases and autoimmune diseases; 4. Patients with high blood pressure, diabetes and heart disease history; 5. Other eye disease history such as uveitis, scleritis and other eye inflammation patients; 6. Patients with scar constitution.
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What it tests

  • Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China)
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Where

1 site
Binocular Wavefront Optometry Machine
Nantong, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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