Status:
RECRUITING
Post Marketing Clinical Study on the Efficacy of Lenses From a New Prescription Protocol
Lead Sponsor:
Essilor International
Conditions:
Ametropia
Refractive Error
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 a...
Detailed Description
This study aims to evaluate whether finer increments in refraction and spectacle lens manufacturing (0.01D) provide more precise visual corrections compared to the traditional 0.25D steps, and if part...
Eligibility Criteria
Inclusion
- 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):
- 35-70 years of age, inclusive
- Currently wearing and adapted to progressive addition lenses
Exclusion
- 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
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07168564
Start Date
September 22 2025
End Date
January 1 2026
Last Update
October 3 2025
Active Locations (1)
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1
Clinical Optics Research Lab @ Borish Center for Ophthalmic Research Indiana University School of Optometry Indiana University
Bloomington, Indiana, United States, 47405