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Clinical observation of SMILE combined with accelerated corneal cross-linking for safe and effective postoperative treatment of myopia

Clinical observation of SMILE combined with accelerated corneal cross-linking for safe and effective postoperative treatment of myopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094262
Enrollment
Unknown
Registered
2024-12-19
Start date
2024-12-20
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Ametropia

Interventions

SMILE Xtra group:Corneal accelerated cross-linking
Conventional SMILE group:None

Sponsors

Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: SMILE group: (1) age >=18 years old; (2) spherical lens degrees -1.00 D- -10.00 D, and columnar lens degrees -5.00 D and below (in accordance with the "Expert Consensus on the Specification of China's Femtosecond Laser Small-Incision Corneal Stromal Lens Removal Surgery 2018"); (3) good fixation in both eyes; (4) refractive stability of more than 2 years (annual refractive change within 0.50 D); (5) Cornea: clear without obvious cloudiness or opacification; normal morphology on corneal topography examination, no tendency to cone cornea; (6) more than 2 weeks of discontinuation of spherical soft lenses, more than 4 weeks of discontinuation of astigmatic soft lenses and rigid oxygen-permeable corneal contact lenses, and more than 12 weeks of discontinuation of keratoplasty lenses. SMILE Xtra group: In addition to the above conditions, (1)Corvis biomechanical index (Corvis biomechanical index (CBI)) > 0.3, corneal topography combined biomechanical index (tomographic biomechanical index (TBI)) > 0.3; (2) expected postoperative corneal stromal bed thickness > 300 µm; (3) corneal thinnest point thickness > 400 µm.

Exclusion criteria

Exclusion criteria: (1) patients with keratoconus and subclinical keratoconus; (2) patients with anterior segment disease, active disease and fundus disease; (3) patients with a history of ocular trauma and surgery; (4) patients with severe diabetes, systemic connective tissue diseases or autoimmune diseases; (5) pregnant and lactating women; (6) patients with anxiety, depression and other serious psychological and mental diseases.

Design outcomes

Primary

MeasureTime frame
Visual acuity(VA);Dioptric;Corneal biomechanical index;Corneal curvature;Corneal thickness;Cornea densito;Intraocular pressure;

Countries

China

Contacts

Public ContactJi Peng

Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine

ji6605@126.com+86 135 7375 3812

Outcome results

None listed

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