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CompletedNCT06021353Updated Dec 27, 2024

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

An interventional study of UV fs-Laser and IR fs-Laser in Refractive Errors, sponsored by Alcon Research. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the detailed 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.

02

Conditions studied

  • Refractive Errors

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03

In context

Refractive Errors

427 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 47 is below the median of 81 across 307 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 100 (90%) have results posted.

Browse Alcon Research studies →All Alcon studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • 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 · Procedure: LASIK

  • 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 · Procedure: LASIK

Interventions

  • DeviceUV fs-Laser

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

    Also known as: WaveLight Ultraviolet Femtosecond Laser Model 1026 with Patient Interface Model 1507

  • DeviceIR fs-Laser

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

    Also known as: WaveLight FS200 Infrared Femtosecond Laser Model 1025 with Patient Interface Model 1515

  • ProcedureLASIK

    Laser-assisted in situ keratomileusis (LASIK) surgery

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Month 1

07

Study locations

1 site
  • Personaleyes
    Sydney, New South Wales 2000, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2023 to primary completion in Dec 2024, 13 months.

Of 122 industry-sponsored interventional studies with no phase under Refractive Errors, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 10. This study's 13 months is above that.

Counting every sponsor, half of 174 studies reached it within 7 months; a quarter within 2 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2023
First posted
Sep 1, 2023
StartActual
Oct 20, 2023
Primary completionActual
Dec 12, 2024
CompletionActual
Dec 12, 2024
Last update
Dec 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06021353
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Sep 1, 2023
Start date
Oct 20, 2023
Primary completion
Dec 12, 2024
Completion
Dec 12, 2024
Last update
Dec 27, 2024

Study contacts

Principal Clinical Trial Lead, CRD Surgical
study director · Alcon Research, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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