The Light Sword Lens for Presbyopia Compensation

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

Detailed Description
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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.

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

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Visual Acuity Examination with a novel lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Visual Acuity Examination with a novel lens|Visual Acuity Examination with a novel lens set in an ophthalmic trial frame|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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presbyopia compensation, EDF, Light Sword Lens