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Investigating the Influence of Preoperative Corneal Biomechanics on Postoperative Biomechanics and Visual Function after SMILE Surgery

Investigating the Influence of Preoperative Corneal Biomechanics on Postoperative Biomechanics and Visual Function after SMILE Surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105312
Enrollment
Unknown
Registered
2025-07-01
Start date
2024-08-19
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Corneal Biomechanics-Related Disorders?

Interventions

Case series:none

Sponsors

School of Ophthalmology & Optometry and Eye Hospital , Wenzhou Medical University , 270 Xueyuan Road , PR China.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age eligibility (>=18 years) with documented refractive stability (=2 weeks, RGP lenses >=4 weeks) with preserved best-corrected visual acuity (BCVA >0.8 Snellen or <=0.1 logMAR) and protocol compliance capacity; (5) Comprehensive ocular health requirements encompassing absence of non-refractive pathology, corneal transparency without significant scarring, and normal topographic findings excluding keratoconus susceptibility based on advanced imaging analysis.

Exclusion criteria

Exclusion criteria: (1) Recent (within 3 months) use of chronic systemic or ocular medications (excluding artificial tears), or presence of systemic diseases that may disrupt ocular homeostasis (e.g., uncontrolled diabetes or autoimmune disorders); (2) Ocular comorbidities including corneal pathologies (keratoconus, scarring, or dystrophies), active ocular surface diseases (conjunctivitis or blepharitis), high myopia complications (retinoschisis or choroidal neovascularization), or other vision-impairing conditions; (3) History of significant ocular trauma or any ocular surgery; (4) Demonstrated inability to comply with study protocols or complete required examinations.

Design outcomes

Primary

MeasureTime frame
Higher-Order Aberrations;Lower-Order Aberrations;Total Aberrations ;Deformation Amplitude;Stiffness Parameter at A1; Corneal Biomechanical Index;

Secondary

MeasureTime frame
Highest Concavity Time;First Applanation Time;Second Applanation Time;

Countries

China

Contacts

Public ContactLiang Hu

School of Ophthalmology & Optometry and Eye Hospital , Wenzhou Medical University , 270

huliang@eye.ac.cn+86 138 6771 0883

Outcome results

None listed

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