LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser

NCT02060461 | Completed Results FDA Device

• 1 other identifier: 11-744
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the visual outcome, accuracy, predictability and complications of LASIK flap creation using the Alcon Wavelight FS200 Femtosecond laser and compare these results to those obtained using current IntraLase FS60 Femtosecond laser. The primary outcome to be evaluated is the flap thickness accuracy.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Evaluation of LASIK Flap Thickness

  Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap.

  3 months

Study Arms (2)

FS200 femtosecond laser LASIK

EXPERIMENTAL

LASIK flap created with an FS200 femtosecond laser system

Device: FS200 femtosecond laser LASIK

IntraLase femtosecond laser LASIK

EXPERIMENTAL

LASIK flap created with an IntraLase femtosecond laser system

Device: IntraLase femtosecond laser LASIK

Interventions

FS200 femtosecond laser LASIK DEVICE

Also known as: Alcon FS200 femtosecond laser

FS200 femtosecond laser LASIK

IntraLase femtosecond laser LASIK DEVICE

Also known as: AMO IntraLase femtosecond laser

IntraLase femtosecond laser LASIK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with ametropia (Spherical, spherocylindrical, presbyopic) suitable for treatment by LASIK, including different target refractions (Plano or Monovision).

You may not qualify if:

• Patients unsuitable for LASIK procedure because of an estimated residual stromal bed \< 300 microns after calculation of the ablation (Corneal thickness - flap thickness - simulated stromal ablation for the desired correction).
• Patients unsuitable for LASIK due suspicious topography for ectasia, form frust keratoconus or unstable ( more than 0.50 diopter change in sphere or cylinder in the last year) refraction.
• Patients with amblyopia or any eye disease that might limit the visual recovery.
• Patients younger than 18 years old.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Alcon Research: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Rocha KM, Krueger RR. Spectral-domain optical coherence tomography epithelial and flap thickness mapping in femtosecond laser-assisted in situ keratomileusis. Am J Ophthalmol. 2014 Aug;158(2):293-301.e1. doi: 10.1016/j.ajo.2014.04.012. Epub 2014 Apr 30.

  PMID: 24792107 RESULT

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: William J Dupps, Jr, MD, PhD
• Organization: Cleveland Clinic

216-444-8396

Study Officials

• William J Dupps, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Contralateral eye study

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: February 12, 2014
• Study Start: August 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2016
• Last Updated: March 23, 2018
• Results First Posted: March 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)