Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06021353




Registration number
NCT06021353
Ethics application status
Date submitted
28/08/2023
Date registered
1/09/2023
Date last updated
25/03/2024

Titles & IDs
Public title
Contralateral Study of WaveLight® Femtosecond Laser Devices for Corneal Flap Creation
Scientific title
Contralateral Study of the WaveLight® Ultraviolet Femtosecond Laser, Model 1026 Versus the WaveLight® FS200 Infrared Femtosecond Laser, Model 1025 for Corneal Flap Creation
Secondary ID [1] 0 0
RFO268-E005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractive Errors 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - UV fs-Laser
Treatment: Devices - IR fs-Laser
Treatment: Surgery - LASIK

Experimental: 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

Active Comparator: 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


Treatment: Devices: UV fs-Laser
Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery

Treatment: Devices: IR fs-Laser
Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery

Treatment: Surgery: LASIK
Laser-assisted in situ keratomileusis (LASIK) surgery
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month
Timepoint [1] 0 0
Month 1

Eligibility
Key inclusion criteria
Key

- Good ocular health;

- Natural lens with no evidence of cataract;

- Eligible for LASIK;

- Stable refraction;

- Other protocol-defined inclusion criteria may apply.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Personaleyes - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alcon Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT06021353
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Principal Clinical Trial Lead, CRD Surgical
Address 0 0
Alcon Research, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alcon Call Center
Address 0 0
Country 0 0
Phone 0 0
1-888-451-3937
Fax 0 0
Email 0 0
alcon.medinfo@alcon.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06021353