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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 acuity, refractive outcomes, contrast sensitivity, and subjective visual quality after SMILE? Are the measurements obtained from different diagnostic devices consistent when evaluating kappa-related parameters? Researchers will compare SMILE with low compensation to SMILE with high compensation to determine which strategy provides better optical quality and visual performance. Participants will: Undergo SMILE surgery using either low or high kappa-angle compensation Complete scheduled postoperative examinations at 1 month, 3 months, and 6 months Receive measurements of visual acuity, refraction, higher-order aberrations, contrast sensitivity, and patient-reported visual outcomes Be monitored for safety outcomes and adverse events during follow-up

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
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• 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.

• Normal corneal morphology and corneal thickness meeting the surgical requirements.

• Best corrected visual acuity (CDVA) before surgery \>= 1.0.

• 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.

• Voluntary to undergo SMILE surgery on the VISUMAX800 platform, understanding the random grouping scheme and signing the informed consent form.

Locations
Other Locations
China
Zhongshan Ophthalmic Center
RECRUITING
Guangzhou
Time Frame
Start Date: 2026-04-08
Estimated Completion Date: 2027-05-30
Participants
Target number of participants: 100
Treatments
Active_comparator: Low-Level compensation group
Subjects underwent SMILE surgery on the VisuMax 800 platform. Preoperatively, decentration coordinates (x, y) were measured. While preserving the directional sign, the absolute value of the planned compensation was set to 50% of the measured decentration; the values were then rounded to the nearest increment permitted by the device input precision and entered into the system. All other surgical procedures, as well as postoperative medication and follow-up protocols, were performed according to a standardized regimen.
Experimental: High-Level compensation group
Subjects also underwent SMILE surgery on the VisuMax 800 platform. Decentration coordinates (x, y) were measured, and the theoretical compensation was set at 100% of the measured decentration. While preserving the directional sign, the measured values were entered directly into the device without any additional adjustment. Except for the different compensation strategy, all other surgical procedures and postoperative management were identical to those of the low-compensation group.
Related Therapeutic Areas
Sponsors
Leads: Zhongshan Ophthalmic Center, Sun Yat-sen University

This content was sourced from clinicaltrials.gov