Corneal Flap Thickness Planed vs Measured After LASIK by Using Tree Different Systems Cut
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Measured thickness flap using Confocal microscopy study
Study Overview
Brief Summary
Determine the flap thickness created by femtosecond laser or a mechanical microkeratome using in vivo confocal microscopy and compare measured versus intended flap thickness.
Detailed Description
Eighty-six eyes had undergone LASIK were examined, al within 2 weeks to 1 month after surgery. Study involved 3 treatment groups: One with 30 eyes of 15 patients, corneal flaps were created with the microkeratome femtosecond laser 15 KHz 100μm (Intralase Corp, Irvine, Calif.), one with 30 eyes of 15 patients, corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif) and one with 26 eyes of 13 patients, corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) . A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) before and at 2 weeks and 1 month after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients ask for LASIK surgery
- •Patients with stable refraction in the last year
- •Patients without systemic and ocular disease
- •Patients with 500 microns in pachymetry
- •Normal topography
Exclusion Criteria
- •Patients cannot attend their appointments
- •Residual, recurrent or active ocular disease
- •Previous ocular surgery except LASIK
- •Autoimmune or connective tissue disease
- •Pregnancy
Arms & Interventions
II
Corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) .
Intervention: LASIK (Procedure)
III
Corneal flaps were created with microkeratome femtoseconds laser (Intralase Corp, Irvine, Calif.)
Intervention: LASIK (Procedure)
I
Corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif)
Intervention: LASIK (Procedure)
Outcomes
Primary Outcomes
Measured thickness flap using Confocal microscopy study
Time Frame: 14 days after LASIK
Secondary Outcomes
No secondary outcomes reported