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

NCT ID: NCT06021353

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-20

Study Completion Date

2024-12-12

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

UV fs-Laser

Intervention Type DEVICE

Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery

LASIK

Intervention Type PROCEDURE

Laser-assisted in situ keratomileusis (LASIK) surgery

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

Group Type OTHER

IR fs-Laser

Intervention Type DEVICE

Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery

LASIK

Intervention Type PROCEDURE

Laser-assisted in situ keratomileusis (LASIK) surgery

Interventions

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UV fs-Laser

Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery

Intervention Type DEVICE

IR fs-Laser

Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery

Intervention Type DEVICE

LASIK

Laser-assisted in situ keratomileusis (LASIK) surgery

Intervention Type PROCEDURE

Other Intervention Names

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WaveLight Ultraviolet Femtosecond Laser Model 1026 with Patient Interface Model 1507 WaveLight FS200 Infrared Femtosecond Laser Model 1025 with Patient Interface Model 1515

Eligibility Criteria

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Inclusion Criteria

* Good ocular health;
* Natural lens with no evidence of cataract;
* Eligible for LASIK;
* Stable refraction;

Exclusion Criteria

* Presence of dry eye;
* Contraindicated systemic disease or ocular conditions;
* Treatment with a contraindicated medication;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Principal Clinical Trial Lead, CRD Surgical

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Personaleyes

Sydney, New South Wales, Australia

Site Status

Countries

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Greece Australia

Other Identifiers

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RFO268-E005

Identifier Type: -

Identifier Source: org_study_id