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OpenTrials
Completed

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.

Completed

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Key information

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

Ophthalmic lens with extra power

Device

Primary outcomes

  1. 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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