Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power

NCT05089240 | Completed

• 1 other identifier: ESS-TEC 191
• Study Type: interventional
• Target: 127
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthenopia

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

20-29 years (+0.40D extra power)

OTHER

Device: Ophthalmic lens with extra power

30-35 years (+0.40D extra power)

OTHER

Device: Ophthalmic lens with extra power

20-29 years (+0.40D extra power with blue cut)

OTHER

Device: Ophthalmic lens with extra power

Interventions

Ophthalmic lens with extra power DEVICE

20-29 years (+0.40D extra power with blue cut); 20-29 years (+0.40D extra power); 30-35 years (+0.40D extra power)

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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…)

Sponsors & Collaborators

• Essilor International: lead
• Elite School of Optometry and Sankara Nethralaya: collaborator

MeSH Terms

Conditions

Asthenopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 22, 2021
• Study Start: June 6, 2016
• Primary Completion: December 2, 2016
• Study Completion: July 1, 2017
• Last Updated: October 22, 2021

Record last verified: 2021-10