The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?

Recruiting now · Not applicable

Conditions studied: Myopia, Refractive Ametropia

In brief

The goal of this clinical trial is to evaluate the effect of intraoperative kappa-angle compensation on postoperative visual quality in patients undergoing small incision lenticule extraction (SMILE) using the VisuMax 800 platform. The study will enroll patients with myopia and a kappa-angle offset \< 0.2 mm. The main questions it aims to answer are: Does intraoperative kappa-angle compensation reduce postoperative higher-order aberrations after SMILE? Does kappa-angle compensation improve postoperative visual quality and refractive outcomes compared with no compensation? Researchers will compare SMILE with intraoperative kappa-angle compensation to SMILE without compensation to determine whether compensation leads to better optical quality and visual performance. Participants will: Undergo SMILE surgery with or without intraoperative kappa-angle compensation Complete scheduled postoperative examinations at 1 week, 1 month, 3 months, and 6 months after surgery Receive measurements of visual acuity, refraction, higher-order aberrations, contrast sensitivity, and safety outcomes

Key facts

Study ID

NCT07512115

Run by

Zhongshan Ophthalmic Center, Sun Yat-sen University

People needed

224

Starts

2026-04-08

Expected to finish

2027-05-30

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18 to 40 years with myopia or myopic astigmatism and stable refraction for >=1 year, whose refractive errors fall within the treatable range of and meet the indications for SMILE surgery.
• Normal corneal morphology and corneal thickness meeting surgical requirements.
• Preoperative corrected distance visual acuity (CDVA) >= 1.0.
• Preoperative synthetic Kappa angle offset measured >= 0.10 mm and < 0.20 mm.
• Voluntarily agree to undergo SMILE surgery on the VISUMAX 800 platform, understand the randomization scheme, and provide signed informed consent.

You may not qualify if…

• History of prior ocular surgery, significant ocular trauma, or presence of corneal or ocular diseases that may affect the safety of refractive surgery.
• Severe systemic diseases that may affect ocular healing or surgical safety.
• Females who are pregnant or lactating.
• Inability to cooperate as required to complete the procedure or follow-up visits.

Where it is running

• Zhongshan Ophthalmic Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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