NCT Number: NCT05089240
Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power
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.
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Notify MeKey information
Conditions
Age range
20 year–39 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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…)
Treatment and study plan
Primary outcomes
-
The difference in number of participants with treatment-related adverse events between the two lenses
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Essilor International
Industry
Collaborators
- Elite School of Optometry and Sankara Nethralaya
Registry information
Official study 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
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2017
- First posted
- Oct 22, 2021
- Registry last updated
- Oct 22, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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