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Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power

E

Essilor

Status

Completed

Conditions

Asthenopia

Treatments

Device: Ophthalmic lens with extra power

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT05089240
ESS-TEC 191

Details and patient eligibility

About

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.

Enrollment

127 patients

Sex

All

Ages

20 to 39 years old

Volunteers

Accepts Healthy Volunteers

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...)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

127 participants in 3 patient groups

20-29 years (+0.40D extra power)
Other group
Treatment:
Device: Ophthalmic lens with extra power
30-35 years (+0.40D extra power)
Other group
Treatment:
Device: Ophthalmic lens with extra power
20-29 years (+0.40D extra power with blue cut)
Other group
Treatment:
Device: Ophthalmic lens with extra power

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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