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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT06021353
Ethics application status
Date submitted
28/08/2023
Date registered
1/09/2023

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

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

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


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
Active, not 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
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
47
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06021353