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

NCT06021353 | Completed

• 1 other identifier: RFO268-E005
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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).

Conditions

Refractive Errors

Outcome Measures

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)

  Month 1

Study Arms (2)

UV fs-Laser

OTHER

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

IR fs-Laser

OTHER

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

UV fs-Laser DEVICE

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

UV fs-Laser

IR fs-Laser DEVICE

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

IR fs-Laser

LASIK PROCEDURE

Laser-assisted in situ keratomileusis (LASIK) surgery

IR fs-Laser; UV fs-Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Good ocular health;
• Natural lens with no evidence of cataract;
• Eligible for LASIK;
• Stable refraction;

You may not qualify if:

• Presence of dry eye;
• Contraindicated systemic disease or ocular conditions;
• Treatment with a contraindicated medication;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Personaleyes

Sydney, New South Wales, 2000, Australia

Location

MeSH Terms

Conditions

Refractive Errors

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Officials

• Principal Clinical Trial Lead, CRD Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 1, 2023
• Study Start: October 20, 2023
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)