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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
120
Participants are prescribed to receive AVA lenses through the AVA protocol and wear these lenses during 2 weeks.
Participants are prescribed to receive Standard lenses through the Gold standard protocol and wear these lenses during 2 weeks.
Clinical Optics Research Lab @ Borish Center for Ophthalmic Research Indiana University School of Optometry Indiana University
Bloomington, Indiana, United States
RECRUITINGVision 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
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
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
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.
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.
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
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
binocular stereo acuity
Summarize binocular stereo acuity with AVA™ lenses and Vision-R 800™
Time frame: 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.
Time frame: immediately after intervention
Duochrome Equality
Summarize relative frequency of Duochrome Equality OD, OS in distance refractive outcomes
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: through study completion, an average of 8 weeks.
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