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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120569
Enrollment
Unknown
Registered
2026-03-17
Start date
2026-03-17
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia or myopic astigmatism

Interventions

High-Level compensation group:Apply high compensation to the Kappa angle.
Low-Level compensation group:Apply low compensation to the Kappa angle.

Sponsors

The Zhongshan Ophthalmic Center,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Total Ocular Aberration;

Secondary

MeasureTime frame
Visual Acuity;Quality of Vision (QoV) Questionnaire;Contrast Sensitivity;Corneal Topography;Refraction and Refractive Outcome;

Countries

China

Contacts

Public ContactGuofu Huang

The Zhongshan Ophthalmic Center,Sun Yat-sen University

hgf2222@sina.com.cn+86 20 6668 6748

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026