The Light Sword Lens for Presbyopia Compensation

Presbyopia Clinical Trial

Official title:

The Light Sword Lens - a Novel Method of Presbyopia Compensation: a Pilot Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716271
• Other study ID #: LSL
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: February 2018

Study information

• Verified date: October 2018
• Source: Military Institute of Medicine, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland	Warsaw University of Technology, Poland

References & 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. — View Citation

Mira-Agudelo A, Torres-Sepúlveda 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ?=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
Primary	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