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The Light Sword Lens for Presbyopia Compensation

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ClinicalTrials.gov Identifier: NCT03716271
Recruitment Status : Completed
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
Warsaw University of Technology, Poland
Information provided by (Responsible Party):
Marek Rekas, Military Institute of Medicine, Poland

Brief Summary:
Clinical assessment of a new optical element for presbyopia compensation - the Light Sword Lens.

Condition or disease Intervention/treatment Phase
Presbyopia Device: Visual Acuity Examination with a novel lens Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Light Sword Lens - a Novel Method of Presbyopia Compensation: a Pilot Clinical Study
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : February 2018

Intervention Details:
  • Device: Visual Acuity Examination with a novel lens
    Visual Acuity Examination with a novel lens set in an ophthalmic trial frame


Primary Outcome Measures :
  1. Visual Acuity based on The Early Treatment Diabetic Retinopathy Study protocol [ Time Frame: day one ]

    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.


  2. Contrast sensitivity based on Pelli-Robson method [ Time Frame: day one ]

    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.




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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716271


Sponsors and Collaborators
Military Institute of Medicine, Poland
Warsaw University of Technology, Poland
Investigators
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Study Director: Krzysztof Petelczyc, PhD Warsaw University of Technology

Publications:
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Responsible Party: Marek Rekas, Professor, Military Institute of Medicine, Poland
ClinicalTrials.gov Identifier: NCT03716271     History of Changes
Other Study ID Numbers: LSL
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: data will be supplemented to published outcomes
Supporting Materials: Study Protocol
Time Frame: data will be supplemented to published outcomes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marek Rekas, Military Institute of Medicine, Poland:
presbyopia compensation
EDF
Light Sword Lens
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases