The Light Sword Lens for Presbyopia Com… | Clinical Trial

Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Visual Acuity Examination with a novel lens

Device

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

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Military Institute od Medicine National Research Institute

Other

Collaborators

Warsaw University of Technology

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2018
First posted: Oct 23, 2018
Registry last updated: Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed