Contralateral Study of WaveLight® Femtosecond Laser Devices for Corneal Flap Creation

March 22, 2024 updated by: Alcon Research

Contralateral Study of the WaveLight® Ultraviolet Femtosecond Laser, Model 1026 Versus the WaveLight® FS200 Infrared Femtosecond Laser, Model 1025 for Corneal Flap Creation

The purpose of this study is to assess the WaveLight Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser) corneal flap creation accuracy as compared to the already marketed WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects who qualify to participate will have both eyes treated in the study (one eye with the UV fs-Laser and the other eye with the IR fs-Laser) and will attend a total of 5 study visits over a period of approximately 2 months. This study will be conducted outside the United States.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Recruiting
        • PersonalEYES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Good ocular health;
  • Natural lens with no evidence of cataract;
  • Eligible for LASIK;
  • Stable refraction;
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Presence of dry eye;
  • Contraindicated systemic disease or ocular conditions;
  • Treatment with a contraindicated medication;
  • Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UV fs-Laser
First surgical eye randomly assigned to the UV fs-Laser with the second surgical eye (fellow eye) assigned to the IR fs-Laser for the purpose of corneal flap creation during LASIK surgery
Device: UV fs-Laser
Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
Other Names:
  • WaveLight Ultraviolet Femtosecond Laser Model 1026 with Patient Interface Model 1507
Procedure: LASIK
Laser-assisted in situ keratomileusis (LASIK) surgery
Active Comparator: IR fs-Laser
First surgical eye randomly assigned to the IR fs-Laser with the second surgical eye (fellow eye) assigned to the UV fs-Laser for the purpose of corneal flap creation during LASIK surgery
Procedure: LASIK
Laser-assisted in situ keratomileusis (LASIK) surgery
Device: IR fs-Laser
Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
Other Names:
  • WaveLight FS200 Infrared Femtosecond Laser Model 1025 with Patient Interface Model 1515

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month
Time Frame: Month 1
Corneal flap thickness will be measured using optical coherence tomography (OCT)
Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Principal Clinical Trial Lead, CRD Surgical, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFO268-E005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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