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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05089240
Other study ID # ESS-TEC 191
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 6, 2016
Est. completion date July 1, 2017

Study information

Verified date October 2021
Source Essilor International
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date July 1, 2017
Est. primary completion date December 2, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 39 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Ophthalmic lens with extra power


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Essilor International Elite School of Optometry and Sankara Nethralaya

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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