Small incision lenticule extraction (SMILE) is a commonly used corneal refractive procedure for correcting myopia and myopic astigmatism. During astigmatism correction, eye rotation between the upright examination position and the supine surgical position may affect the alignment of the astigmatic treatment axis and may contribute to residual astigmatism after surgery.
Manual limbal marking is a commonly used method to guide cyclotorsion adjustment during refractive surgery. OcuLign is an assisted cyclotorsion control function of the VISUMAX 800 platform that helps identify ocular rotation and guide axis alignment during SMILE. However, direct clinical evidence comparing OcuLign-assisted cyclotorsion control with manual limbal marking during SMILE is limited.
This study is a single-center, prospective, randomized, masked, contralateral-eye non-inferiority trial. Adults aged 18 to 40 years with stable myopia and astigmatism who plan to undergo bilateral SMILE surgery will be enrolled. In each participant, one eye will receive SMILE with OcuLign-assisted cyclotorsion control, and the fellow eye will receive SMILE with manual limbal marking-guided cyclotorsion adjustment. The treatment assigned to the right eye will be determined by randomization.
The primary objective is to compare residual refractive astigmatism at 3 months after surgery between the two methods. Secondary outcomes include visual acuity, refractive predictability and stability, astigmatism vector analysis, higher-order aberrations, contrast sensitivity, patient-reported quality of vision, overall satisfaction, and safety outcomes. Participants will be followed for approximately 6 months after surgery.
Age range: 18 - 40 years old. Patients with myopic astigmatism and stable refractive status for >= 1 year.
Normal corneal morphology in both eyes, with corneal thickness and other ocular parameters meeting the requirements for SMILE surgery.
Preoperative corrected distance visual acuity (CDVA) >= 1.0 in both eyes.
Manifest refractive cylinder >= 0.75 D in both eyes, with an interocular difference in absolute cylinder power <= 1.00 D.
History of prior ocular surgery, significant ocular trauma, or presence of ocular diseases that may affect the safety of refractive surgery or the interpretation of study outcomes.
Irregular astigmatism or poor repeatability of bilateral astigmatism measurements, making reliable astigmatic axis analysis impossible.
Presence of strabismus, nystagmus, significant binocular vision abnormality, or any condition that may affect fixation or cooperation during examinations.
Severe systemic diseases that may affect ocular healing or surgical safety.