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Completed
NCT07168564
Post Marketing Clinical Study on the Efficacy of Lenses From a New Prescription Protocol
Conditions: Ametropia, Refractive Error
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Essilor International
Location: Clinical Optics Research Lab @ Borish Center for Ophthalmic Research Indiana University School of Optometry Indiana University Bloomington Indiana
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 Criteria
Inclusion Criteria:
1. Age between 18 y/o and 70
2. Accepted and signed the consent form
3. Agree to participate in the scheduled visits
4. Best-corrected visual acuity by manifest refraction of +0.10 log MAR (20/25 Snellen) or better in each eye
5. Spherical Equivalent Refractive Error between -10.00 and 10.00 D
6. Possess current wearable and visually functional eyeglasses
7. 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.
8. No binocular vision issues
9. No cataract, grade 2 or greater
Presbyope subjects: To be eligible for the presbyopic group, individuals need to be (half of the analyzed population):
10. 35-70 years of age, inclusive
11. Currently wearing and adapted to progressive addition lenses
Exclusion Criteria:
1. Less than 18 years or greater than 70 years of age
2. Does not wear spectacles at least 6 hours/day
3. Does not have a wearable pair of glasses with a prescription ≤2 years old
4. Currently or formerly a licensed optometrist, optician, or ophthalmic technician trained in refraction
Source: ClinicalTrials.gov (NCT07168564). StuddyBuddy aggregates publicly available trial information.