search
Back to results

The Light Sword Lens for Presbyopia Compensation

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Visual Acuity Examination with a novel lens
Sponsored by
Military Institute od Medicine National Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring presbyopia compensation, EDF, Light Sword Lens

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • emmetropic or hyperopic eyes with a spherical error of maximum +1.75D and astigmatism of ≤ 0.5D.
  • Corrected distance visual acuity (CDVA) had to be better than 0.1 logMAR (20/25) and at the same time contrast sensitivity (CS) could not be less than 1.9 logCS. -Uncorrected near visual acuity was required to be worse than 0.4 logMAR (20/50), as a proof of presbyopia.

Exclusion Criteria:

  • any history of ophthalmic surgeries
  • evidence of serious ocular or brain pathologies affecting visual acuity (VA)
  • clinically active inflammation.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Visual Acuity based on The Early Treatment Diabetic Retinopathy Study protocol
    Examination for visual performance in 3 trials: reference (with lens for distance correction); stenopeic (distance correction with a pinhole ϕ=1,25 mm) and Light Sword Lens (distance correction with a Light Sword Lens). In each trial, visual acuity assessment in 7 tasks for defocus from 0.2D to 3.0D. The degree of homogeneity through defocus was determined. Reference and stenopeic trials were compared to Light Sword Lens results. Statistical analysis: Friedman analysis of variance, Nemenyi post-hoc, Wilcoxon tests , p-value < 0.05 is considered significant.
    Contrast sensitivity based on Pelli-Robson method
    Contrast sensitivity assessment in 2 tasks for defocus 0.3D and 2.5D The degree of homogeneity through defocus was determined. Reference and stenopeic trials were compared to Light Sword Lens results. Statistical analysis: Friedman analysis of variance, Nemenyi post-hoc, Wilcoxon tests , p-value < 0.05 is considered significant.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 10, 2018
    Last Updated
    October 22, 2018
    Sponsor
    Military Institute od Medicine National Research Institute
    Collaborators
    Warsaw University of Technology
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03716271
    Brief Title
    The Light Sword Lens for Presbyopia Compensation
    Official Title
    The Light Sword Lens - a Novel Method of Presbyopia Compensation: a Pilot Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (Actual)
    Primary Completion Date
    April 2017 (Actual)
    Study Completion Date
    February 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Military Institute od Medicine National Research Institute
    Collaborators
    Warsaw University of Technology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Clinical assessment of a new optical element for presbyopia compensation - the Light Sword Lens.
    Detailed Description
    Healthy dominant eyes of presbyopes were examined for visual performance. The examination was performed in the ophthalmic trial frame, which included assessment of 3 trials: reference (with lens for distance correction); stenopeic (distance correction with a pinhole ϕ=1,25 mm) and Light Sword Lens (distance correction with a Light Sword Lens). In each trial, visual acuity was assessed in 7 tasks for defocus from 0.2D to 3.0D while contrast sensitivity in 2 tasks for defocus 0.3D and 2.5D.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Presbyopia
    Keywords
    presbyopia compensation, EDF, Light Sword Lens

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Visual Acuity Examination with a novel lens
    Intervention Description
    Visual Acuity Examination with a novel lens set in an ophthalmic trial frame
    Primary Outcome Measure Information:
    Title
    Visual Acuity based on The Early Treatment Diabetic Retinopathy Study protocol
    Description
    Examination for visual performance in 3 trials: reference (with lens for distance correction); stenopeic (distance correction with a pinhole ϕ=1,25 mm) and Light Sword Lens (distance correction with a Light Sword Lens). In each trial, visual acuity assessment in 7 tasks for defocus from 0.2D to 3.0D. The degree of homogeneity through defocus was determined. Reference and stenopeic trials were compared to Light Sword Lens results. Statistical analysis: Friedman analysis of variance, Nemenyi post-hoc, Wilcoxon tests , p-value < 0.05 is considered significant.
    Time Frame
    day one
    Title
    Contrast sensitivity based on Pelli-Robson method
    Description
    Contrast sensitivity assessment in 2 tasks for defocus 0.3D and 2.5D The degree of homogeneity through defocus was determined. Reference and stenopeic trials were compared to Light Sword Lens results. Statistical analysis: Friedman analysis of variance, Nemenyi post-hoc, Wilcoxon tests , p-value < 0.05 is considered significant.
    Time Frame
    day one

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: emmetropic or hyperopic eyes with a spherical error of maximum +1.75D and astigmatism of ≤ 0.5D. Corrected distance visual acuity (CDVA) had to be better than 0.1 logMAR (20/25) and at the same time contrast sensitivity (CS) could not be less than 1.9 logCS. -Uncorrected near visual acuity was required to be worse than 0.4 logMAR (20/50), as a proof of presbyopia. Exclusion Criteria: any history of ophthalmic surgeries evidence of serious ocular or brain pathologies affecting visual acuity (VA) clinically active inflammation.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Krzysztof Petelczyc, PhD
    Organizational Affiliation
    Warsaw University of Technology
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    data will be supplemented to published outcomes
    IPD Sharing Time Frame
    data will be supplemented to published outcomes
    Citations:
    PubMed Identifier
    26137376
    Citation
    Kakarenko K, Ducin I, Grabowiecki K, Jaroszewicz Z, Kolodziejczyk A, Mira-Agudelo A, Petelczyc K, Skladowska A, Sypek M. Assessment of imaging with extended depth-of-field by means of the light sword lens in terms of visual acuity scale. Biomed Opt Express. 2015 Apr 16;6(5):1738-48. doi: 10.1364/BOE.6.001738. eCollection 2015 May 1.
    Results Reference
    background
    PubMed Identifier
    28002561
    Citation
    Mira-Agudelo A, Torres-Sepulveda W, Barrera JF, Henao R, Blocki N, Petelczyc K, Kolodziejczyk A. Compensation of Presbyopia With the Light Sword Lens. Invest Ophthalmol Vis Sci. 2016 Dec 1;57(15):6870-6877. doi: 10.1167/iovs.16-19409.
    Results Reference
    background

    Learn more about this trial

    The Light Sword Lens for Presbyopia Compensation

    We'll reach out to this number within 24 hrs