The Light Sword Lens for Presbyopia Compensation

Military Institute od Medicine National Research Institute34 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Presbyopia

Interventions

Visual Acuity Examination with a novel lensDEVICE

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

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: day one

Data from ClinicalTrials.gov

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