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

NCT07168564 | Recruiting FDA Device

• 1 other identifier: WS10425
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ametropia; Refractive Error

Keywords

Corrective eye glasses

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (24)

• Subjective Binocular Vision Quality

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

• Subjective Binocular Vision

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

• Accuracy of refraction

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

• accuracy of refraction

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

• perceived refraction experience

  immediately after the intervention

Study Arms (2)

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.

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.

Device: AVA lenses; Device: Standard lenses

Interventions

AVA lenses DEVICE

Participants are prescribed to receive AVA lenses through the AVA protocol and wear these lenses during 2 weeks.

First Essilor® AVA™ and then Standard; First Standard then Essilor® AVA™

Standard lenses DEVICE

Participants are prescribed to receive Standard lenses through the Gold standard protocol and wear these lenses during 2 weeks.

First Essilor® AVA™ and then Standard; First Standard then Essilor® AVA™

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• years of age, inclusive
• Currently wearing and adapted to progressive addition lenses

You may not qualify if:

• 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

Sponsors & Collaborators

• Essilor International: lead

Study Sites (1)

Clinical Optics Research Lab @ Borish Center for Ophthalmic Research Indiana University School of Optometry Indiana University

Bloomington, Indiana, 47405, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 22647932 BACKGROUND

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Pete Kollbaum, Professor

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pete Kollbaum, Professor

CONTACT

812-855-5500; CORL@iu.edu

Dawn Meyer, OD, FAAO

CONTACT

812-855-5500; CORL@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Post-Marketing Clinical Study : Monocentric, 2 arms, crossover, prospective, interventional, double masked clinical study, with within-subject control

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 11, 2025
• Study Start: September 22, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)