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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVA lenses | Device | Participants are prescribed to receive AVA lenses through the AVA protocol and wear these lenses during 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vision correction preference | Proportion of subjects preferring vision correction option between Essilor® AVA™ lenses and the alternative vision correction solution | through study completion, an average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately after the intervention, and through study completion, an average of 8 weeks |
| Subjective Binocular Vision |
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Inclusion Criteria:
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 Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pete Kollbaum, Professor | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Optics Research Lab @ Borish Center for Ophthalmic Research Indiana University School of Optometry Indiana University | Bloomington | Indiana | 47405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22647932 | Background | 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. | |
| 37861987 | Background | 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. |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Post-Marketing Clinical Study : Monocentric, 2 arms, crossover, prospective, interventional, double masked clinical study, with within-subject control
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| Standard lenses | Device | Participants are prescribed to receive Standard lenses through the Gold standard protocol and wear these lenses during 2 weeks. |
|
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 |
| 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. | 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 | 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. | 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. | 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) | 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) | 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. | 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. | 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™. | 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 | 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™. | 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. | 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. | 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. | 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™ | 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. | immediately after intervention |
| Duochrome Equality | Summarize relative frequency of Duochrome Equality OD, OS in distance refractive outcomes | 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. | 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. | 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) | 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. | 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 | through study completion, an average of 8 weeks. |