NCT01941498

Brief Summary

The purpose of this study is to evaluate outcomes of subjects undergoing myopic surgery using the WaveLight® Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 11, 2015

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

September 10, 2013

Results QC Date

February 1, 2015

Last Update Submit

October 2, 2015

Conditions

Refractive Error

Keywords

nearsightedfarsightedastigmatismLASIKrefractive surgeryWaveLight

Outcome Measures

Primary Outcomes (1)

  • Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA

    Visual acuity (VA) with corrective devices (BCVA) was assessed binocularly (both eyes together) pre-treatment and subtracted from VA without spectacles or other visual corrective devices (UCVA) assessed binocularly at 1 month post-treatment. VA was measured at a distance of 4 meters and reported in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A negative value indicates an improvement in VA from pre-treatment to Month 1.

    Month 1

Secondary Outcomes (13)

  • Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT

    Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative

  • Mean Manifest Refraction (Sphere)

    Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative

  • Mean Manifest Refraction (Cylinder)

    Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative

  • Mean Laser Treatment Time

    Day 0 (surgery)

  • Mean Total Laser Treatment Time

    Day 0 (surgery)

  • +8 more secondary outcomes

Study Arms (1)

WaveLight Refractive Suite

EXPERIMENTAL

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

Device: Wavelight® Refractive SuiteProcedure: LASIK surgery

Interventions

Wavelight® Refractive SuiteDEVICE

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

WaveLight Refractive Suite
LASIK surgeryPROCEDURE

Surgical procedure for treating refractive error based on corneal reshaping

WaveLight Refractive Suite

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • History of dry eye that is unresponsive to treatment.
  • Severe ocular allergies.
  • Other medical conditions and use of medications as specified in protocol.
  • Pregnant or planning to become pregnant during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Refractive ErrorsMyopiaHyperopiaAstigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Clinical Project Lead, GCRA, Surgical
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Clinical Manager, GMA, Surgical

    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

September 1, 2013

Primary Completion

January 1, 2014

Study Completion

August 1, 2014

Last Updated

November 3, 2015

Results First Posted

March 11, 2015

Record last verified: 2015-10