Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power

Asthenopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05089240
• Other study ID #: ESS-TEC 191
• Status: Completed
• Phase: N/A
• 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
• 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…)

Related Conditions & MeSH terms

• Asthenopia

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)