Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power

Not Applicable

Completed

• Conditions: Asthenopia
• Interventions: Device: Ophthalmic lens with extra power

• Registration Number: NCT05089240
• Lead Sponsor: Essilor International

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-06
• Primary Completion: 2016-12-02
• Study Completion: 2017-07-01
• Study First Submitted: 2021-09-28
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-10
• Last Update Submitted: 2021-10-10
• Study First Posted: 2021-10-22
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
30-35 years (+0.40D extra power)	Ophthalmic lens with extra power	-
20-29 years (+0.40D extra power with blue cut)	Ophthalmic lens with extra power	-
20-29 years (+0.40D extra power)	Ophthalmic lens with extra power	-

Primary Outcome Measures

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