Active — Not RecruitingNot Applicable

Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation

Australia128 participantsStarted 2025-08-27

Plain-language summary

The purpose of this study is to see how safe the WaveLight Ultraviolet Femtosecond Laser, Model 1026 (UV fs-Laser), is for creating corneal flaps during laser-assisted in situ keratomileusis (LASIK) surgery. This study will be conducted in Australia.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Eligible for LASIK treatment; * 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); * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * An active implanted device for which laser use may be a contraindication; * 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; * Other protocol-defined exclusion criteria may apply.

What they're measuring

Difference of intended and achieved flap thickness measured at center (i.e., corneal apex)

Timeframe: Month 1

Difference of flap thickness measured between central (i.e., corneal apex) and periphery (i.e., 3 millimeter radius)

Timeframe: Month 1

Ability to lift flap at time of surgery

Timeframe: Day 0 Surgery

Ocular adverse events (AEs) related to corneal flap creation with UV fs-Laser and IR fs-Laser

Timeframe: Day 0 Surgery up through Month 3

Flap-related loss of best-corrected distance visual acuity (BCDVA) greater than or equal to 2 lines (greater than or equal to 10 letters logMAR) at 1 month postoperative or later

Timeframe: Month 1 up to Month 3

Number of device deficiencies

Timeframe: Day 0 Surgery through Month 3

Trial details

NCT IDNCT07036835

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

View on ClinicalTrials.gov More Refractive Errors trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Difference of intended and achieved flap thickness measured at center (i.e., corneal apex)

Timeframe: Month 1

Difference of flap thickness measured between central (i.e., corneal apex) and periphery (i.e., 3 millimeter radius)

Timeframe: Month 1

Ability to lift flap at time of surgery

Timeframe: Day 0 Surgery

Ocular adverse events (AEs) related to corneal flap creation with UV fs-Laser and IR fs-Laser

Timeframe: Day 0 Surgery up through Month 3

Flap-related loss of best-corrected distance visual acuity (BCDVA) greater than or equal to 2 lines (greater than or equal to 10 letters logMAR) at 1 month postoperative or later

Timeframe: Month 1 up to Month 3

Number of device deficiencies

Timeframe: Day 0 Surgery through Month 3