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The clinical study of corneal refractive surgery with femtosecond laser

The clinical study of corneal refractive surgery with femtosecond laser

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-13003114
Enrollment
Unknown
Registered
2013-03-17
Start date
2008-09-20
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Myopia

Interventions

femtosecond LASIK group:femtosecond LASIK
ReLEx group:femtosecond lenticule extraction
LASEK group:LASEK

Sponsors

Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Myopia Key Laboratory of the Health Ministry
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: The patients are unsatisfactory correction with spectacles or contact lenses and ask for refractive surgery; a minimum age of 18 years, stable myopia for at least 1 year, corrected distance visual acuity (CDVA)>= 20 / 25 (>=0.80), sufficient corneal thickness (estimated total postoperative corneal thickness >400um and estimated residual thickness of the stromal bed >250um); and no other ocular diseases or conditions except myopia with or without astigmatism.

Exclusion criteria

Exclusion criteria: Exclusion criteria were suspicion of keratectasia, active ocular disease and history of prior ocular surgery or trauma, or any contraindications for the refractive procedure.

Design outcomes

Primary

MeasureTime frame
Visual acuity;manifest refraction;corneal tomography;corneal and ocular aberrations;intraocular pressure;Corneal Sensitivity;Confocal microscopic examination;Anterior segment optical coherence tomography examination;Corneal biomechanics examination;Ocular Surface Disease Index (OSDI);Tear film breakup time (TBUT);the Schirmer test without anesthesia (S1T);corneal fluorescein staining;slit-lamp examination;subjective scale;

Countries

China

Contacts

Public ContactXingtao Zhou
doctzhouxingtao@163.com+86 13816880725

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 10, 2026