AmetropiaATLANTICNCT07168564
Post Marketing Clinical Study on the Efficacy of Lenses From a New Prescription Protocol
A study testing AVA lenses and Standard lenses in people with Ametropia and Refractive Error, run by Essilor International at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ametropia, Refractive Error
- What is being tested?
- AVA lenses and Standard lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2025to 28 May 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Optics Research Lab @ Borish Center for Ophthalmic Research Indiana University School of Optometry Indiana University
Bloomington, Indiana, 47405
About this study
Official title: Post Market Clinical Study to Compare Vision With Essilor® AVA™ Lenses Following AVA™ Refraction Protocol to Equivalent Lenses Following Gold Standard Refraction Protocol.
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.
Read the 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 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.
- Conditions
- Ametropia, Refractive Error
- Being tested
- AVA lenses, Standard lenses
- Keywords
- Corrective eye glasses
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVA lensesDevice
Participants are prescribed to receive AVA lenses through the AVA protocol and wear these lenses during 2 weeks.
Standard lensesDevice
Participants are prescribed to receive Standard lenses through the Gold standard protocol and wear these lenses during 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| First Essilor® AVA™ and then Standard | Experimental | 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. Receives: Device: AVA lenses; Device: Standard lenses |
| First Standard then Essilor® AVA™ | Experimental | 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. Receives: Device: AVA lenses; Device: Standard lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision correction preference
Proportion of subjects preferring vision correction option between Essilor® AVA™ lenses and the alternative vision correction solution
Measured: through study completion, an average of 8 weeks
Secondary outcomes (24)
Subjective Binocular Vision Quality
Scores of self-reported Subjective Binocular Vision Quality questionnaire OU (0-100 rating) at Distance vision, Near work and Overall Quality of Vision.
Measured: immediately after the intervention, and through study completion, an average of 8 weeks
Subjective Binocular Vision
P-value of superiority Wilcoxon signed rank test comparing the Scores regarding Subjective Binocular Vision obtained with Essilor® AVA™ lenses and with Essilor® non-AVA™ lenses
Measured: immediately after the intervention, and through study completion, an average of 8 weeks
Accuracy of refraction
Scores of self-reported perceived accuracy of refraction OU (0-100 rating) obtained with AVA™ Smart program and with standard refraction.
Measured: immediately after the intervention, and through study completion, an average of 8 weeks.
accuracy of refraction
P-value of superiority Wilcoxon signed rank test comparing the Scores of self-reported perceived accuracy of refraction OU (0-100 rating) obtained with AVA™ Smart program and with standard refraction
Measured: immediately after the intervention, and through study completion, an average of 8 weeks.
perceived refraction experience
Score of self-reported perceived refraction experience of refraction OU (0-100 rating) obtained with AVA™ Smart program and with standard refraction.
Measured: immediately after the intervention
Refraction experience accuracy of refraction
P-value of superiority Wilcoxon signed rank test comparing the Scores of self-reported refraction experience accuracy of refraction OU (0-100 rating) obtained with AVA™ Smart program and with standard refraction.
Measured: through study completion, an average of 8 weeks.
Subjective refraction experience
Score of self-reported Subjective refraction experience with Essilor® AVA™ lenses in following 2 weeks of wear - Comparison in High contrast, high illumination logMAR Visual Acuity (4m, OU (M\&S)) with refractive outcome (superiority test)
Measured: immediately after intervention
Subjective Vision Quality with Essilor® AVA™ lenses
P-value of superiority Wilcoxon signed rank test comparing the Scores of self-reported Subjective Vision Quality with Essilor® AVA™ lenses in following 2 weeks of wear - Comparison in High contrast, high illumination logMAR Visual Acuity (4m, OU (M\&S)) with refractive outcome (superiority test)
Measured: immediately after intervention, through study completion, an average of 8 weeks.
Binocular high-contrast, high-illumination logMAR distance visual acuity
Binocular high-contrast, high-illumination logMAR distance visual acuity with AVA™ lenses and Vision-R™ 800.
Measured: immediately after intervention, through completion of study, an average of 8 weeks.
binocular high-contrast high-illumination distance visual acuity
P-value of superiority Wilcoxon signed rank test comparing binocular high-contrast high-illumination distance visual acuity with the AVA™ Smart Program refraction results and Essilor® AVA™ lenses manufactured from this prescription, over the standard refraction results and corresponding Essilor® non-AVA™ lenses.
Measured: immediately after intervention, through completion of study, an average of 8 weeks.
Binocular low-contrast high-illumination distance logMAR visual acuity
Binocular low-contrast high-illumination distance logMAR visual acuity with Essilor® AVA™ lenses and Vision-R 800™.
Measured: immediately after intervention, through completion of study, an average of 8 weeks.
binocular low-contrast high-illumination distance log MAR visual acuity
P-value of superiority Wilcoxon signed rank test comparing binocular low-contrast high-illumination distance log MAR visual acuity with the AVA™ Smart Program refraction results and Essilor® AVA™ lenses manufactured from this prescription over the standard refraction results and corresponding Essilor® non-AVA™ lenses
Measured: immediately after intervention, through completion of study, an average of 8 weeks.
Binocular low-contrast low-illumination distance logMAR visual acuity
Binocular low-contrast low-illumination distance logMAR visual acuity with Essilor® AVA™ lenses and Vision-R 800™.
Measured: immediately after intervention, through completion of study, an average of 8 weeks.
binocular low-contrast low-illumination distance log MAR visual acuity
P-value of superiority Wilcoxon signed rank test comparing binocular low-contrast low-illumination distance log MAR visual acuity with the AVA™ Smart Program refraction results and Essilor® AVA™ lenses manufactured from this prescription over the standard refraction results and corresponding Essilor® non-AVA™ lenses.
Measured: immediately after intervention, through completion of study, an average of 8 weeks.
Binocular distance contrast sensitivity
Binocular distance contrast sensitivity (4m, OU) with refractive outcome.
Measured: immediately after intervention, through completion of study, an average of 8 weeks.
Binocular distance contrast sensitivity
P-value of superiority Wilcoxon signed rank test comparing Binocular distance contrast sensitivity with the AVA™ Smart Program refraction results and Essilor® AVA™ lenses manufactured from this prescription over the standard refraction results and Essilor® non-AVA™ lenses.
Measured: immediately after intervention, through completion of study, an average of 8 weeks.
binocular stereo acuity
Summarize binocular stereo acuity with AVA™ lenses and Vision-R 800™
Measured: immediately after intervention
binocular stereo acuity
Mean difference in binocular stereo acuity (4m, Vision-R 800™ system) with the AVA™ Smart Program refraction results and prescribed Essilor® AVA™ lenses over the standard refraction results and corresponding Essilor® non-AVA™ lenses.
Measured: immediately after intervention
Duochrome Equality
Summarize relative frequency of Duochrome Equality OD, OS in distance refractive outcomes
Measured: immediately after intervention
relative frequency of Duochrome Equality
P-value of McNemar test comparing the relative frequency of Duochrome Equality OD, OS with AVA™ Smart Program refraction and with the standard refraction.
Measured: through study completion, an average of 8 weeks.
5-point Likert
P-value of Wilcoxon signed rank test comparing the relative frequencies of responses on a 5-point Likert (distance, near) scale preferring AVA™ Smart program refraction and/or standard refraction assessment.
Measured: through study completion, an average of 8 weeks.
relative frequencies of scores
P-value of Wilcoxon signed rank test comparing the relative frequencies of scores assessing lenses Essilor® AVA™ and non-AVA™ lenses following masked in-office trial (5-point Likert; Distance vision, Near work (phone reading), Computer, Across a room, Visual Comfort, Color Vision/Contrast Depth perception, Overall Quality of Vision, Overall satisfaction)
Measured: through study completion, an average of 8 weeks.
scores assessing lenses in Subjective Vision Quality
P-value of Wilcoxon signed rank test comparing the relative frequencies of scores assessing lenses Essilor® AVA™/non AVA™ lenses in Subjective Vision Quality - OU (0-100 rating; Day driving, Night driving, Computer, across a room, Visual Comfort, Color Vision/Contrast, Depth Perception, Overall Quality of Vision, Adaptation speed, Ease of Adaptation, Overall satisfaction) following two weeks of wear.
Measured: through study completion, an average of 8 weeks.
scores assessing lenses evaluated by Patient (Preference)
P-value of Wilcoxon signed rank test comparing the relative frequencies of scores assessing Essilor® AVA™/non-AVA™ lenses evaluated by Patient (Preference) - better confidence in refraction, higher satisfaction with refraction
Measured: through study completion, an average of 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start22 Sep 2025
- Primary completion28 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmetropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Post-Marketing Clinical Study : Monocentric, 2 arms, crossover, prospective, interventional, double masked clinical study, with within-subject control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pete Kollbaum, Professor, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168564
- Sponsor's protocol ID
- WS10425
- Acronym
- ATLANTIC
- Status last verified
- Jun 2026
- First submitted
- 26 Aug 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kollbaum PS, Jansen ME, Rickert ME. Comparison of patient-reported visual outcome methods to quantify the perceptual effects of defocus. Cont Lens Anterior Eye. 2012 Oct;35(5):213-21. doi: 10.1016/j.clae.2012.05.001. Epub 2012 May 28.
PubMed 22647932Meyer D, Rickert M, Reed O, Joret P, Kollbaum P. Clinical Comparison of High-resolution and Standard Refractions and Prescriptions. Optom Vis Sci. 2023 Nov 1;100(11):751-760. doi: 10.1097/OPX.0000000000002076.
PubMed 37861987