The Light Sword Lens for Presbyopia Compensation

NCT03716271 | Completed

• 1 other identifier: LSL
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Presbyopia

Keywords

presbyopia compensation; EDF; Light Sword Lens

Outcome Measures

Primary Outcomes (2)

• 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.

  day one

• 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.

  day one

Interventions

Visual Acuity Examination with a novel lens DEVICE

Visual Acuity Examination with a novel lens set in an ophthalmic trial frame

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead
• Warsaw University of Technology: collaborator

Related Publications (2)

• 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.

  PMID: 26137376 BACKGROUND

• 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.

  PMID: 28002561 BACKGROUND

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Krzysztof Petelczyc, PhD

  Warsaw University of Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 23, 2018
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: February 1, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data will be supplemented to published outcomes