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

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

NCT Number	NCT07512115
Lead Sponsor	Zhongshan Ophthalmic Center, Sun Yat-sen University
Conditions	Myopia, Refractive Ametropia
Enrollment	224 participants
Start Date	2026-04-08
Primary Completion	2027-05-30 (estimated)
Study Completion	2027-05-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-07