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

Essilor

Status: Enrolling

Conditions: Refractive Error; Ametropia

Treatments: Device: Standard lenses; Device: AVA lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT07168564

WS10425

Details and patient eligibility

About

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.

Full 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 participants can visually appreciate this difference in the refractive outcome and manufactured lenses. It will assess improvements in visual acuity, comfort, and patient satisfaction, focusing on achieving red-green equality in the duo chrome test and exploring the clinical utility of higher resolution refraction technologies.

Refraction is a critical procedure in eye care that determines the optimal lens power for a focused retinal image. Traditional manual phoropters, the standard for over a century, operate in 0.25D increments but have limitations, as most individuals are sensitive to smaller power variations. Recent technological advancements, such as digital phoropters like the Vision-R™ 800, allow for continuous power adjustments in increments as fine as 0.01D and support manufacturing spectacles in smaller steps.

While these innovations offer theoretical advantages, their clinical impact remains relatively underexplored. This study addresses this gap by comparing traditional and finer increment prescriptions to assess improvements in visual performance and patient outcomes. Results could redefine refraction standards and optimize optometric care practices.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

First Essilor® AVA™ and then Standard

Experimental group

Description:

Participants are first prescribed for AVA™ protocol and then for Standard protocol . Patients will first wear the Essilor® AVA™ lenses during 2 weeks. Then, after a washout period of 2 weeks, patients will wear the Standard lenses during 2 weeks.

Treatment:

Device: AVA lenses

Device: Standard lenses

First Standard then Essilor® AVA™

Experimental group

Description:

Participants are first prescribed for Standard protocol and then for AVA™ protocol . Patients will first wear the Standard lenses during 2 weeks. Then, after a washout period of 2 weeks, patients will wear the Essilor® AVA™ lenses during 2 weeks.

Treatment:

Device: AVA lenses

Device: Standard lenses