0.05 D precision refraction to improve SMILE and FS‑LASIK vision
Official title: Clinical Application Research of 5-Degree (0.05 D) Precision Optometry in Corneal Refractive Surgery
Run by Affiliated Hospital of Nantong University · NCT07146828 · Data updated 2026-11-12
This project will try using very fine (0.05 diopter) refraction measurements before SMILE or FS‑LASIK for adults 18–40 to see if they get sharper vision after surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Locations | 1 site (Nantong, Jiangsu) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | October 1, 2025 |
| Study ends | October 1, 2026 |
| Registry record updated | August 28, 2025 |
| Trial ID | NCT07146828 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–40 with stable myopic refraction, good preoperative corrected visual acuity, appropriate contact lens washout, and who plan to undergo SMILE or FS‑LASIK are ideal candidates.
✕Probably not a fit
Patients with prior eye surgery or trauma, keratoconus or suspected ectasia, active ocular inflammation, significant systemic disease (eg, uncontrolled hypertension, diabetes, heart disease), scar tendency, or unstable refraction are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective study enrolls patients scheduled for SMILE or FS‑LASIK at the Affiliated Hospital of Nantong University and measures preoperative refraction with a binocular wavefront aberrometer at 0.05 D increments. The 0.05 D refraction values will be entered into the VisuMax Precision 4.0 system for SMILE or applied with the FS‑LASIK manufacturer nomogram to guide surgical input. Patients will be followed at 10 days, 1 month, 3 months, 6 months and 1 year to record uncorrected and best‑corrected visual acuity, spherical and cylindrical power, spherical equivalent, and higher‑order aberrations. Primary outcomes are postoperative UCVA and BCVA and the proportion of patients reaching specified UCVA thresholds, with secondary outcomes including residual refractive error and aberrations.
Why it matters
Potential benefit: If successful, this approach could reduce residual refractive errors after corneal refractive surgery and improve uncorrected visual acuity and overall visual quality.
How similar studies have gone: Prior reports document residual refractive errors after SMILE and that many people detect changes smaller than 0.25 D, but applying 0.05 D surgical inputs is relatively novel and has limited direct outcome data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Binocular Wavefront Optometry Machine
Nantong, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Ying Yu, MD
- Email: yuying.2009@163.com
- Phone: +86 159 9662 1616
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Corneal Biomechanical Measurements to Guide Refractive Surgery
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.