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

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Alcon

Status

Active, not recruiting

Conditions

Refractive Errors

Treatments

Device: UV fs-Laser
Device: IR fs-Laser
Procedure: LASIK

Study type

Interventional

Funder types

Industry

Identifiers

NCT06021353
RFO268-E005

Details and patient eligibility

About

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).

Full 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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

47 participants in 2 patient groups

UV fs-Laser
Other group
Description:
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
Treatment:
Procedure: LASIK
Device: UV fs-Laser
IR fs-Laser
Other group
Description:
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
Treatment:
Procedure: LASIK
Device: IR fs-Laser

Trial contacts and locations

1

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Central trial contact

Alcon Call Center

Data sourced from clinicaltrials.gov

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