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The Light Sword Lens for Presbyopia Compensation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03716271
Enrollment
34
Registered
2018-10-23
Start date
2016-04-30
Completion date
2018-02-28
Last updated
2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia

Keywords

presbyopia compensation, EDF, Light Sword Lens

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.

Interventions

DEVICEVisual Acuity Examination with a novel lens

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

Sponsors

Warsaw University of Technology
CollaboratorOTHER
Military Institute od Medicine National Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Acuity based on The Early Treatment Diabetic Retinopathy Study protocolday oneExamination 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 methodday oneContrast 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026