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A comparative study of SMILE Xtra and SMILE in myopic patients from the perspectives of postoperative efficacy, corneal biomechanics and visual quality

A comparative study of SMILE Xtra and SMILE in myopic patients from the perspectives of postoperative efficacy, corneal biomechanics and visual quality

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103311
Enrollment
Unknown
Registered
2025-05-27
Start date
2024-07-20
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Myopia

Interventions

smile group:smile operation
smile xtra group:smile xtra operation

Sponsors

Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria 1.The age range is from 18 to 50 years old; 2.The change in diopter within two years is =20/25; 4.The preoperative corneal stromal thickness was >=470 µ m. According to the Randleman dilation Risk Score, patients with a moderate to high dilation risk score (score >=3); 5.The estimated residual stromal bed thickness (RST) after lens removal is >=270um; 6.Soft contact lenses should be discontinued for at least one week, hard contact lenses for at least three weeks, and orthokeratology lenses for at least three months.

Exclusion criteria

Exclusion criteria: 1.Other eye diseases: keratoconus or suspected keratoconus, active keratoconjunctivitis, severe dry eye, glaucoma, etc; 2.Obvious scarring or lens opacity on the cornea affects observation; 3.There is active inflammation throughout the body, connective tissue disease or other systems that prevent cooperation with the surgery; 4.Sexual disorders or mental disorders; 5.There is a history of eye surgery in the past; 6.Those who are allergic to the components of surgical drugs.

Design outcomes

Primary

MeasureTime frame
Visual quality satisfaction score;

Secondary

MeasureTime frame
Corneal biomechanical parameter ;Visual quality scoring indicators;Aberration;UCVA, uncorrected distant visual acuity;BCVA, best corrected visual acuity;Corneal curvature;Equivalent spherical lens;Astigmatism;Corneal fog condition;intraocular pressure;The number of corneal endothelial cells;Anterior segment OCT corneal cross-linking line;

Countries

China

Contacts

Public ContactJinhui Dai

Zhongshan Hospital Affiliated to Fudan University

dai.jinhui@zs-hospital.sh.cn+86 138 1688 0422

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026