Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power

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

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.

Study Overview

• Status: Completed
• Conditions: Asthenopia
• Intervention / Treatment: Device: Ophthalmic lens with extra power

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Essilor International
• Collaborators: Elite School of Optometry and Sankara Nethralaya

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2016
• Primary Completion (Actual): December 2, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 10, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 10, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Asthenopia
• Other Study ID Numbers: ESS-TEC 191

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No