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Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power

Sponsor
Essilor International (Industry)
Overall Status
Completed
CT.gov ID
NCT05089240
Collaborator
Elite School of Optometry and Sankara Nethralaya (Other)
127
Enrollment
3
Arms
12.8
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ophthalmic lens with extra power
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
127 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
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
Actual Study Start Date :
Jun 6, 2016
Actual Primary Completion Date :
Dec 2, 2016
Actual Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: 20-29 years (+0.40D extra power)

Device: Ophthalmic lens with extra power
Other: 30-35 years (+0.40D extra power)

Device: Ophthalmic lens with extra power
Other: 20-29 years (+0.40D extra power with blue cut)

Device: Ophthalmic lens with extra power

Outcome Measures

Primary Outcome Measures

  1. The difference in number of participants with treatment-related adverse events between the two lenses [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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…)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Essilor International
  • Elite School of Optometry and Sankara Nethralaya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Essilor International
ClinicalTrials.gov Identifier:
NCT05089240
Other Study ID Numbers:
  • ESS-TEC 191
First Posted:
Oct 22, 2021
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Asthenopia

Study Results

No Results Posted as of Oct 22, 2021