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Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial

RecruitingNAAges 18 Years - 40 YearsAllZhongshan Ophthalmic Center, Sun Yat-sen Universi…
NCT07512102 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to compare two intraoperative kappa-angle compensation strategies during small incision lenticule extraction (SMILE) using the VisuMax 800 platform in patients with relatively large kappa-angle offsets. Angle kappa represents the difference between the visual axis and the pupil center. In patients with a large offset, pupil-centered treatment may lead to decentration of the optical zone, which can induce higher-order aberrations and affect postoperative visual quality. The VisuMax 800 system allows intraoperative adjustment of the treatment center based on the measured offset, making different compensation strategies possible. The main questions this study aims to answer are: Does low kappa-angle compensation (50%) result in lower postoperative higher-order aberrations than high compensation (100%)? Does the compensation strategy influence visual acu

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age range: 18 - 40 years old. Patients with stable refractive status for \>= 1 year, having myopia or myopic astigmatism, with refractive power within the range of SMILE procedure. 2. Normal corneal morphology and corneal thickness meeting the surgical requirements. 3. Best corrected visual acuity (CDVA) before surgery \>= 1.0. 4. The kappa angle-related offset coordinates (x, y) obtained before surgery, with the absolute value of either \|x\| or \|yl\| of any eye \>= 0.20mm. 5. Voluntary to undergo SMILE surgery on the VISUMAX800 platform, understanding the random grouping scheme and signing the informed consent form. Exclusion Criteria: 1. History of prior ocular surgery, significant ocular trauma, or presence of corneal or ocular diseases that may affect the safety of refractive surgery. 2. Severe systemic diseases that may affect ocular healing or surgical safety. 3. Females who are pregnant or lactating. 4. Inability to cooperate as required to complete the procedure or follow-up visits.
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What it tests

  • Apply high compensation to the Kappa angle.
  • Apply low compensation to the Kappa angle.
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Where

1 site
Zhongshan Ophthalmic Center
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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