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

Essilor International0 sites127 target enrollmentJune 6, 2016

ConditionsAsthenopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Asthenopia
Sponsor: Essilor International
Enrollment: 127
Primary Endpoint: The difference in number of participants with treatment-related adverse events between the two lenses
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 6, 2016

End Date

July 1, 2017

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Essilor International

Responsible Party

Sponsor

Eligibility Criteria

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...)

Outcomes

Primary Outcomes

The difference in number of participants with treatment-related adverse events between the two lenses

Time Frame: Immediately after the first and second wearing period (21 days each)

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.