RecruitingNot ApplicableNCT07168564

Post Marketing Clinical Study on the Efficacy of Lenses From a New Prescription Protocol

Post Market Clinical Study to Compare Vision With Essilor® AVA™ Lenses Following AVA™ Refraction Protocol to Equivalent Lenses Following Gold Standard Refraction Protocol.


Sponsor

Essilor International

Enrollment

120 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to assess improvements in visual performance and patient outcomes in wearing new spectacle lenses in general population. The two spectacle lenses will be compared after two weeks of wearing. The aims are: * to evaluate the visual superiority, and quality-of-life implications of Essilor® AVA™ spectacle lenses prescribed after a new subjective refraction protocol named AVA™ protocol. * to understand the benefits of using a high accuracy instrument and testing sequence over the standard testing sequence in determining a glasses prescription, as well as the overall subjective performance of the resulting glasses.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria12

  • Age between 18 y/o and 70
  • Accepted and signed the consent form
  • Agree to participate in the scheduled visits
  • Best-corrected visual acuity by manifest refraction of +0.10 log MAR (20/25 Snellen) or better in each eye
  • Spherical Equivalent Refractive Error between -10.00 and 10.00 D
  • Possess current wearable and visually functional eyeglasses
  • Agree to wear the assigned frames fitted with the provided lenses for a minimum of 14 days, during 6h/day, equivalent to 42 hours of wearing a week.
  • No binocular vision issues
  • No cataract, grade 2 or greater
  • Presbyope subjects: To be eligible for the presbyopic group, individuals need to be (half of the analyzed population):
  • years of age, inclusive
  • Currently wearing and adapted to progressive addition lenses

Exclusion Criteria4

  • Less than 18 years or greater than 70 years of age
  • Does not wear spectacles at least 6 hours/day
  • Does not have a wearable pair of glasses with a prescription ≤2 years old
  • Currently or formerly a licensed optometrist, optician, or ophthalmic technician trained in refraction

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Interventions

DEVICEAVA lenses

Participants are prescribed to receive AVA lenses through the AVA protocol and wear these lenses during 2 weeks.

DEVICEStandard lenses

Participants are prescribed to receive Standard lenses through the Gold standard protocol and wear these lenses during 2 weeks.


Locations(1)

Clinical Optics Research Lab @ Borish Center for Ophthalmic Research Indiana University School of Optometry Indiana University

Bloomington, Indiana, United States

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NCT07168564


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