What is this study trying to find out about refractive surgery?

This study is evaluating whether using a higher precision refraction method with 0.05 diopter increments before SMILE and FS-LASIK surgeries can improve patients' postoperative vision quality. It aims to see if more precise measurements lead to better visual outcomes after surgery. The research is sponsored by the Affiliated Hospital of Nantong University and focuses on improving vision correction techniques.

Who may be eligible for this refractive surgery clinical trial?

Adults aged 18 to 40 with stable vision prescriptions and good preoperative corrected vision may be eligible. Participants must be willing to undergo SMILE or FS-LASIK surgery and meet certain contact lens wear requirements before surgery. There are also exclusions for eye conditions and systemic diseases. Please review eligibility criteria for more details.

Is there any cost to participate in this refractive surgery clinical trial?

Study-related care, including the study procedure and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 40Years

All Genders

ID07146828

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

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Myopia is increasing rapidly worldwide, with projections estimating nearly half the global population affected by 2050. Corneal refractive surgeries like SMILE and FS-LASIK are common methods to correct myopia, but some patients experience overcorrection or undercorrection after surgery due to limitations in preoperative refraction precision. This trial investigates whether using a binocular wavefront optometry machine to perform 0.05 D precision refraction before surgery can improve postoperative visual quality in patients undergoing these procedures. The study involves two groups one receiving traditional refraction methods and the other using 0.05 D precision refraction with the Binocular Wavefront Optometry Machine for surgical planning. Eligible patients opting for SMILE or FS-LASIK will have their precise refraction data entered into surgical platforms, which then guide the refractive correction during surgery. Follow-up visits are scheduled at 10 days, 1 month, 3 months, 6 months, and 1 year to monitor outcomes. Participants will undergo assessments including uncorrected and best-corrected visual acuity, spherical and cylindrical power measurements, spherical equivalent, and ocular aberrations at multiple time points before and after surgery. Safety monitoring includes intraocular pressure and anterior segment examinations. The study aims to measure the proportion of patients achieving specific visual acuity levels and refractive accuracy, with data collected over a one-year postoperative period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 40Years

All Genders

Eligibility Criteria

You may qualify if you...

Stable vision prescription with changes less than 0.50 diopters per year for 2 consecutive years
Age between 18 and 40 years
Optimal preoperative corrected visual acuity of 4.8 or better
No soft contact lens use for at least 2 weeks and no hard contact lens use for at least 3 months before surgery
Willingness to undergo SMILE surgery

You will not qualify if you...

History of eye surgery or eye trauma
Tendency toward keratoconus
Presence of systemic connective tissue 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
Scar-prone constitution

Research Team

Ying Yu, MD

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