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Comparison of Two Rotational Alignment Methods for Astigmatism Correction in SMILE Surgery

Comparison of Astigmatic Correction Outcomes Following SMILE With OcuLign-Assisted Cyclotorsion Control and Manual Limbal Marking: A Prospective Randomized Contralateral-Eye Noninferiority Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127928
Enrollment
Unknown
Registered
2026-07-10
Start date
2026-07-13
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Myopic astigmatism

Interventions

Manual limbal marking rotational alignment group:Manual limbal marking rotational alignment
OcuLign-assisted cyclotorsion control group:OcuLign-assisted cyclotorsion control

Sponsors

Zhongshan Ophthalmic Center,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 to 40 years with myopic astigmatism and stable refraction for at least 1 year. 2.Both eyes have normal corneal morphology and meet the indications for SMILE, including adequate corneal thickness. 3.Preoperative corrected distance visual acuity (CDVA) is 1.0 or better. 4.The absolute value of manifest refractive astigmatism is =0.75 D in both eyes, with an inter-eye difference in absolute cylinder =1.00 D. 5.Reliable preoperative seated-axis information for astigmatic alignment can be obtained in both eyes, and the investigator judges that the eyes meet the requirements for OcuLign cyclotorsion recognition and axis alignment on the VISUMAX 800 platform. 6.Patients voluntarily agree to undergo SMILE with the VISUMAX 800 platform, understand the randomization scheme, and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.History of ocular surgery, significant ocular trauma, or ocular diseases that may affect the safety or outcome assessment of refractive surgery. 2.Irregular astigmatism or poor repeatability of astigmatism measurements in either eye, making reliable axis analysis impossible. 3.Presence of strabismus, nystagmus, significant binocular visual dysfunction, or conditions affecting fixation or cooperation during examinations. 4.Severe systemic diseases that may affect ocular healing or surgical safety. 5.Pregnant or lactating women. 6.Patients unable to complete postoperative follow-up visits or questionnaire assessments as required.

Design outcomes

Primary

MeasureTime frame
Residual astigmatism at 3 months postoperatively;

Secondary

MeasureTime frame
Astigmatic vector analysis parameters;Contrast Sensitivity;Visual Acuity;Predictability of astigmatic correction;Corneal Topography;Total Ocular Aberration;Refraction and Refractive Outcome;Quality of Vision (QoV) Questionnaire;

Countries

China

Contacts

Public ContactGuofu Huang

Zhongshan Ophthalmic Center,Sun Yat-sen University

hgf2222@sina.com.cn+86 198 9829 8088

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026