CClinicalTrials.gg
CompletedNCT07168564ATLANTICUpdated Jun 9, 2026

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

An interventional study of AVA lenses and Standard lenses in Ametropia and Refractive Error, sponsored by Essilor International. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Essilor International · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.
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.

02

Conditions studied

  • Ametropia
  • Refractive Error

Browse trials for

Keywords

  • Corrective eye glasses
03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 120 is above the median of 82 across 296 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Essilor International is the lead sponsor of 38 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    First Essilor® AVA™ and then Standard

    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.

    Device: AVA lenses · Device: Standard lenses

  • Experimental
    First Standard then Essilor® AVA™

    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.

    Device: AVA lenses · Device: Standard lenses

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.

06

What researchers measure

Primary outcomes

  1. Vision correction preference

    Proportion of subjects preferring vision correction option between Essilor® AVA™ lenses and the alternative vision correction solution

    Time frame: through study completion, an average of 8 weeks

Secondary outcomes

  1. 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.

    Time frame: immediately after the intervention, and through study completion, an average of 8 weeks

  2. 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

    Time frame: immediately after the intervention, and through study completion, an average of 8 weeks

  3. Accuracy of refraction

    Scores of self-reported perceived accuracy of refraction OU (0-100 rating) obtained with AVA™ Smart program and with standard refraction.

    Time frame: immediately after the intervention, and through study completion, an average of 8 weeks.

  4. 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

    Time frame: immediately after the intervention, and through study completion, an average of 8 weeks.

  5. 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.

    Time frame: immediately after the intervention

  6. 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.

    Time frame: through study completion, an average of 8 weeks.

  7. 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)

    Time frame: immediately after intervention

  8. 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)

    Time frame: immediately after intervention, through study completion, an average of 8 weeks.

  9. 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.

    Time frame: immediately after intervention, through completion of study, an average of 8 weeks.

  10. 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.

    Time frame: immediately after intervention, through completion of study, an average of 8 weeks.

  11. 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™.

    Time frame: immediately after intervention, through completion of study, an average of 8 weeks.

  12. 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

    Time frame: immediately after intervention, through completion of study, an average of 8 weeks.

  13. 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™.

    Time frame: immediately after intervention, through completion of study, an average of 8 weeks.

  14. 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.

    Time frame: immediately after intervention, through completion of study, an average of 8 weeks.

  15. Binocular distance contrast sensitivity

    Binocular distance contrast sensitivity (4m, OU) with refractive outcome.

    Time frame: immediately after intervention, through completion of study, an average of 8 weeks.

  16. 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.

    Time frame: immediately after intervention, through completion of study, an average of 8 weeks.

  17. binocular stereo acuity

    Summarize binocular stereo acuity with AVA™ lenses and Vision-R 800™

    Time frame: immediately after intervention

  18. 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.

    Time frame: immediately after intervention

  19. Duochrome Equality

    Summarize relative frequency of Duochrome Equality OD, OS in distance refractive outcomes

    Time frame: immediately after intervention

  20. 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.

    Time frame: through study completion, an average of 8 weeks.

  21. 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.

    Time frame: through study completion, an average of 8 weeks.

  22. 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)

    Time frame: through study completion, an average of 8 weeks.

  23. 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.

    Time frame: through study completion, an average of 8 weeks.

  24. 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

    Time frame: through study completion, an average of 8 weeks.

07

Study locations

1 site
  • Clinical Optics Research Lab @ Borish Center for Ophthalmic Research Indiana University School of Optometry Indiana University
    Bloomington, Indiana 47405, United States
08

References and documents

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 22647932 ↗
  • Meyer 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07168564
Lead sponsor
Essilor International
Responsible party
Sponsor
First posted
Sep 11, 2025
Start date
Sep 22, 2025
Primary completion
May 28, 2026
Completion
May 28, 2026
Last update
Jun 9, 2026

Study contacts

Pete Kollbaum, Professor
principal investigator · Indiana University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion