WaveLight® Refractive Flap Accuracy Study

NCT ID: NCT01941485

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-02-28

Brief Summary

The purpose of this study is to evaluate the accuracy of the WaveLight FS200 femtosecond laser, as assessed by 1 day and 1 month post-operative optical coherence tomography (OCT) anterior segment corneal measurements compared to pre-operative flap thickness target.

Conditions

Refractive Error

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WaveLight Refractive Suite

LASIK surgery (laser in situ keratomileusis) per standard of care

Group Type: EXPERIMENTAL

WaveLight® Refractive Suite

Intervention Type: DEVICE

Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation

LASIK surgery

Intervention Type: PROCEDURE

Surgical procedure for treating refractive error based on corneal reshaping

Interventions

WaveLight® Refractive Suite

Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation

Intervention Type: DEVICE

LASIK surgery

Surgical procedure for treating refractive error based on corneal reshaping

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Willing and able to understand and sign an informed consent form.
• Have refractive error (in both eyes) that requires refractive surgery.
• Willing to undergo LASIK surgery using the Wavelight® Refractive Suite.
• Myopia between 0.00 to -12.0 Diopters pre-operatively.
• Astigmatism between 0.00 to +6.00 Diopters pre-operatively.
• Willing and able to attend post-operative examinations per protocol schedule.

Exclusion Criteria

• Participation in a clinical study within the last 30 days.
• History of previous corneal surgery in either eye.
• Multifocal ablations in either eye.
• PRK or PTK surgery in either eye.
• Suffering from acute or recurring eye diseases in either eye, such as corneal ulcers, cataract, etc.
• Any ocular disease and/or condition that, in the Investigator's clinical judgment, may put subject at significant risk, compromise study results, or interfere significantly with subject's participation in the study.
• Unable to discontinue contact lens wear as specified in protocol.
• History of Herpes simplex or Herpes zoster keratitis.
• Active ocular rosacea.
• Lyme disease.
• Severe ocular allergies.
• Other medical conditions and use of medications as specified in protocol.
• Pregnant or planning to become pregnant during the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sr. Clinical Manager, GCRA, Global Med Affairs, Operations

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

A01354

Identifier Type: -

Identifier Source: org_study_id