Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power

Study Overview
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Brief Summary
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To evaluate subjective visual performance and objective visual parameters when wearing ophthalmic lenses with extra power (+0.4 D or +0.6 D), and ophthalmic lenses with a selective blue cut filter.

Official Title
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Data Collection of Objective Parameters and Subjective Feedback on Visually Fatigued Subjects and Evaluation of the Effect of Ophthalmic Lenses to Alleviate Visual Fatigue

Conditions
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Asthenopia

Intervention / Treatment
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* Device: Ophthalmic lens with extra power


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjective report of visual fatigue Non-presbyopes Permanent wearers who wear glasses for at least 5 hours a day Distance refractive error within the range of [+6.00 to -6.00]* (with cylinder in the negative form), Cylindrical component of the refractive error within the range of 0 to 2 D in both eyes, Anisometropia ≤ 1.00 D in sperical equivalent, Visual acuity of +0.10 logMAR or better in each eye with new prescription at distance (high contrast/high luminance), Distance visual acuity difference ≤0.20 logMAR between right and left eye (high contrast, high luminance) Near binocular visual acuity of +0.10 logMAR or better with a new prescription (high contrast, high luminance), Study frame characteristics: Frame B size at least 22 mm Exclusion Criteria: Vulnerability of the subject, Participation in another study which might have an influence on vision or interfere with study assessments, Binocular vision problems, Known ocular pathology (e.g., age-related macular degeneration, glaucoma…), Any previous ocular surgery which might have an influence on vision or interfere with study assessments (e.g., iridectomy, refractive surgery…), Any untreated and/or uncontrolled systemic condition which might have an influence on vision, or interfere with study assessments (e.g., uncontrolled diabetes, uncontrolled high blood pressure…), Any medical treatment or medication that might have an influence on vision or interfere with study assessments (e.g., antidepressants, drugs with atropinic effects…), Knowledge/expertise in optometry, ophthalmic lenses, or optics based on past or current professional activity (e.g., optometrists, opticians, ophthalmologists…)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 20-29 years (+0.40D extra power)<br> | Device: Ophthalmic lens with extra power<br> <br> |
| Other: 30-35 years (+0.40D extra power)<br> | Device: Ophthalmic lens with extra power<br> <br> |
| Other: 20-29 years (+0.40D extra power with blue cut)<br> | Device: Ophthalmic lens with extra power<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in number of participants with treatment-related adverse events between the two lenses | Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device. Determined by subject's spontaneous reporting, the Investigator's non-leading questioning and his/her evaluation. | Immediately after the first and second wearing period (21 days each) |