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
52 weeks
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo corneal refractive surgery (SMILE or FS-LASIK) with surgical parameters optimized using 0.05 D high-precision refraction from a binocular wavefront aberrometer.
1 visit (in-person, surgical procedure)
Duration - 1 year
Participants attend follow-up examinations to assess visual outcomes and safety after surgery.
5 visits at 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively
Trial Site Locations
Total: 1 location
1
Binocular Wavefront Optometry Machine
Nantong, Jiangsu, China, 226001
Actively Recruiting
Research Team
Y
Ying Yu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here