Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation
NCT ID: NCT07036835
Last Updated: 2026-01-13
Study Results
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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RECRUITING
NA
174 participants
INTERVENTIONAL
2025-08-27
2026-11-30
Brief Summary
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Detailed Description
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Subjects will attend a total of 6 scheduled study visits, including a preoperative Screening Visit (Day -45 to -1), a Surgery Visit (Day 0), and 4 postoperative visits at Day 1, Week 1, Month 1, and Month 3/exit, for a total individual duration of participation of approximately 4 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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UV fs-Laser/Anesthetic 1 Right, IR fs-Laser/Anesthetic 1 Left
LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 1 eye drops
LASIK Surgery
Laser assisted in situ keratomileusis (LASIK) surgery conducted for the purpose of correcting refractive error
UV fs-Laser
WaveLight Ultraviolet Femtosecond Laser used for creating a corneal flap during LASIK surgery
IR fs-Laser
WaveLight FS200 Infrared Femtosecond Laser used for creating a corneal flap during LASIK surgery
Anesthetic 1 eye drops
Topical anesthetic used to numb the surface of the eye
UV fs-Laser/Anesthetic 1 Left, IR fs-Laser/Anesthetic 1 Right
LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 1 eye drops
LASIK Surgery
Laser assisted in situ keratomileusis (LASIK) surgery conducted for the purpose of correcting refractive error
UV fs-Laser
WaveLight Ultraviolet Femtosecond Laser used for creating a corneal flap during LASIK surgery
IR fs-Laser
WaveLight FS200 Infrared Femtosecond Laser used for creating a corneal flap during LASIK surgery
Anesthetic 1 eye drops
Topical anesthetic used to numb the surface of the eye
UV fs-Laser/Anesthetic 2 Right, IR fs-Laser/Anesthetic 2 Left
LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 2 eye drops
LASIK Surgery
Laser assisted in situ keratomileusis (LASIK) surgery conducted for the purpose of correcting refractive error
UV fs-Laser
WaveLight Ultraviolet Femtosecond Laser used for creating a corneal flap during LASIK surgery
IR fs-Laser
WaveLight FS200 Infrared Femtosecond Laser used for creating a corneal flap during LASIK surgery
Anesthetic 2 eye drops
Topical anesthetic used to numb the surface of the eye
UV fs-Laser/Anesthetic 2 Left, IR fs-Laser/Anesthetic 2 Right
LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 2 eye drops
LASIK Surgery
Laser assisted in situ keratomileusis (LASIK) surgery conducted for the purpose of correcting refractive error
UV fs-Laser
WaveLight Ultraviolet Femtosecond Laser used for creating a corneal flap during LASIK surgery
IR fs-Laser
WaveLight FS200 Infrared Femtosecond Laser used for creating a corneal flap during LASIK surgery
Anesthetic 2 eye drops
Topical anesthetic used to numb the surface of the eye
Interventions
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LASIK Surgery
Laser assisted in situ keratomileusis (LASIK) surgery conducted for the purpose of correcting refractive error
UV fs-Laser
WaveLight Ultraviolet Femtosecond Laser used for creating a corneal flap during LASIK surgery
IR fs-Laser
WaveLight FS200 Infrared Femtosecond Laser used for creating a corneal flap during LASIK surgery
Anesthetic 1 eye drops
Topical anesthetic used to numb the surface of the eye
Anesthetic 2 eye drops
Topical anesthetic used to numb the surface of the eye
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Myopia as specified in the protocol;
* Uncorrected distance visual acuity of greater than or equal to 0.30 logMAR;
* Best corrected distance visual acuity of less than or equal to 0.10 logMAR;
* Presence of clear natural lens (non-cataractous eye);
Exclusion Criteria
* Previous ocular surgery;
* Ocular conditions that may affect subject safety or impact study outcomes;
* Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study;
* Current use of medications with known ocular side effects and photosensitivity;
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Lead, Surgical
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Personaleyes
Sydney, New South Wales, Australia
Countries
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Central Contacts
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Other Identifiers
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RFO268-C009
Identifier Type: -
Identifier Source: org_study_id
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