WaveLight® Refractive Flap Accuracy Study

NCT01941485 | Completed Results

• 1 other identifier: A01354
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Keywords

nearsighted; astigmatism; LASIK; refractive surgery; WaveLight

Outcome Measures

Primary Outcomes (1)

• The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively

  The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness at Day 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.

  Day 1 Postoperative

Secondary Outcomes (21)

• Incidence of Development of Opaque Bubble Layer (OBL)

  Operation/Surgery (Day 1)

• Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap

  Operation/Surgery (Day 1)

• The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively

  Month 1 Postoperative

• Uncorrected Visual Acuity (UCVA)

  Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative

• Best Corrected Visual Acuity (BCVA)

  Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative

Study Arms (1)

WaveLight Refractive Suite

EXPERIMENTAL

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

Device: WaveLight® Refractive Suite; Procedure: LASIK surgery

Interventions

WaveLight® Refractive Suite DEVICE

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

WaveLight Refractive Suite

LASIK surgery PROCEDURE

Surgical procedure for treating refractive error based on corneal reshaping

WaveLight Refractive Suite

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors; Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Global Brand Med Affairs Lead, Refractive, VGR
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

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

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 13, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2015
• Last Updated: January 4, 2017
• Results First Posted: February 12, 2015

Record last verified: 2016-11