Skip to content

Effects of corneal biomechanics on corneal epithelial remodeling and visual quality after SMILE

Effects of corneal biomechanics on corneal epithelial remodeling and visual quality after SMILE

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099218
Enrollment
Unknown
Registered
2025-03-19
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

refractive error

Interventions

Low CBI Group:None
High CBI Group:None

Sponsors

The Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 or older, with stable spherical equivalent refraction over the past 12 months (change less than +/-0.5 D). 2. Spherical power between -1.00 D and -10.00 D, cylindrical power <=3.00 D, and the sum of the absolute values of spherical and cylindrical powers <=10.00 D. 3. Intraocular pressure between 10 and 21 mmHg (1 mmHg = 0.133 kPa). 4. Discontinuation of soft contact lenses for at least 2 weeks and rigid gas-permeable contact lenses for at least 4 weeks. 5. Clear cornea without significant opacity or nebula, normal corneal topography, and no signs of keratoconus.

Exclusion criteria

Exclusion criteria: 1. History of eye trauma or surgery; 2. Corneal contact lens-related epithelial changes; 3. Any contraindications to SMILE (such as keratoconus); 4. Pregnancy or breastfeeding during the study; 5. Other eye diseases; 6. Systemic organic lesions affecting post-operative recovery.

Design outcomes

Primary

MeasureTime frame
Corneal epithelial thickness;Corneal biomechanical parameters;aberration;

Secondary

MeasureTime frame
visual acuity without correction;spherical equivalent;intraocular pressure;

Countries

China

Contacts

Public ContactHu Liang

The Eye Hospital of Wenzhou Medical University

liang_hu@live.cn+86 88068862

Outcome results

None listed

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