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Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03021707
Collaborator
(none)
7
Enrollment
4
Locations
1
Arm
31.3
Actual Duration (Months)
1.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.

Condition or Disease Intervention/Treatment Phase
  • Device: WaveLight® Ultraviolet Femtosecond (FS) Laser System
  • Procedure: Laser Assisted Lenticular Extraction
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction
Actual Study Start Date :
Mar 7, 2017
Actual Primary Completion Date :
May 27, 2019
Actual Study Completion Date :
Oct 17, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: UV-FS laser

WaveLight® Ultraviolet Femtosecond Laser System during UV-Femto, single session (one treatment per eye per participant)

Device: WaveLight® Ultraviolet Femtosecond (FS) Laser System
Utilizes ultraviolet (UV) light with a wavelength of 347 nanometers (nm) for refractive error correction
Other Names:
  • Model 1026
  • UV-FS laser

    • Procedure: Laser Assisted Lenticular Extraction
    Used for refractive error correction
    Other Names:
  • UV-Femto

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Presence of optical treatment zone corneal haze [Up to Month 6 (post-operative)]

      Corneal haze will be assessed on a scale of 0 to 4, where 0 = clear or no haze can be seen, and 4 = opacity is visible without slit lamp, greatly obscures iris detail.

    2. Mean change from screening in presence of disruption in the integrity of retinal layers in the macula [Screening, Up to Month 6 (post-operative)]

      Retinal layer integrity will be assessed by a posterior segment ocular coherence tomography (OCT) scan of the study eye. Any disruption (change) in the retinal layers in the macula as compared to the screening scan will assess retinal integrity.

    3. Mean percentage change in average endothelial cell density (ECD) from screening to each visit post procedure [Screening, Up to Month 6 (post-operative)]

      Specular microscopy will be performed on the study eye and endothelial cell density will be recorded.

    4. Mean percentage change in lens opacification from screening to each visit post procedure [Screening, Up to Month 6 (post-operative)]

      A Scheimpflug scan will be performed to evaluate any opacification of the crystalline lens in the study eye and a Pentacam Nucleus Staging (PNS) grade from 0 to 5 will be assigned.

    5. Mean percentage change in foveal thickness from screening to each visit post procedure [Screening, Up to Month 6 (post-operative)]

      Foveal thickness will be assessed by a posterior segment OCT scan of the study eye.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Photopic distance visual acuity worse than best corrected visual acuity (BCVA) 20/400 in the study eye;

    • Myopia with manifest refraction spherical equivalent (MRSE) of - 1.50 diopter (D) or higher in the study eye;

    • Able to comprehend and provide documented informed consent;

    • Willing and able to comply with schedule for follow-up visits;

    • Minimum required endothelial cell density (ECD) in study eye as outlined in the protocol;

    • Presence of natural lens in study eye;

    • A treatment simulation with spectacles or contact lenses on the study eye does not negatively impact participant's daily activities;

    • Other protocol-specified inclusion criteria may apply.

    Exclusion Criteria:

    • Pregnant or nursing;

    • Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study as clinically assessed by the Investigator;

    • Active implanted device, including but not limited to, heart pacemaker or defibrillator, for which laser use may be a contraindication;

    • Current use of medications with known ocular side effects;

    • Predicted residual stromal bed thickness <300 micrometers (μm) in study eye

    • Ocular conditions in the study eye;

    • Previous ocular surgery in the study eye that resulted in corneal distortions within the treatment zone;

    • Residual, recurrent or active ocular disease that may impact study outcomes;

    • Previous or current diagnosis of dry eye;

    • Known allergic reaction to medications expected to be used preoperatively, during laser refractive surgery, and for postoperative care;

    • Pre-existing corneal opacities in study eye;

    • Contact lens worn in study eye and not removed prior to study testing affected by wear per timeframe specified in the protocol;

    • Other protocol-specified exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alcon Investigative Site Sioux Falls South Dakota United States 57108
    2 Alcon Investigative Site Houston Texas United States 77027
    3 Alcon Investigative Site Dublin Ireland 18
    4 Alcon Investigative Site Singapore Singapore 168751

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Clinical Manager, Surgical, Alcon Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT03021707
    Other Study ID Numbers:
    • RFO268-E001
    First Posted:
    Jan 16, 2017
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Myopia
    Refractive Errors

    Study Results

    No Results Posted as of Apr 7, 2022