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

RECRUITING

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).

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Good ocular health

Natural lens with no evidence of cataract

Eligible for LASIK

Stable refraction

Other protocol-defined inclusion criteria may apply

Exclusion criteria

Presence of dry eye

Contraindicated systemic disease or ocular conditions

Treatment with a contraindicated medication

Other protocol-defined exclusion criteria may apply

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-10-20

Primary completion: 2024-12-01

Study completion finish: 2024-12-01

Study type

TREATMENT

Phase

Trial ID

NCT06021353

Intervention or treatment

DEVICE: UV fs-Laser

DEVICE: IR fs-Laser

PROCEDURE: LASIK

Conditions

• Refractive Errors

$Image related to Refractive Errors$

Condition: Refractive Errors
DEVICE: UV fs-Laser and other drugs
Sydney, New South Wales, Australia
Sponsor: Alcon Research

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Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Personaleyes

Research sites nearby

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Personaleyes
Sydney, New South Wales, Australia

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?

Participant Group/Arm	Intervention/Treatment
OTHER: 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: 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	DEVICE: IR fs-Laser Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery

What is the study measuring?

Primary outcome

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

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Contralateral Study of WaveLight® Femtosecond Laser Devices for Corneal Flap Creation