Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID07168564

Post Market Clinical Study to Compare Vision With Essilor4 AVA22 Lenses Using AVA22 Refraction Protocol Versus Gold Standard Refraction Protocol

Led by Essilor International · Updated on 2025-10-03

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating new spectacle lenses made with finer increments in lens power prescription to see if they improve visual performance and patient satisfaction compared to traditional lenses. The study focuses on general population adults with refractive errors, aiming to assess the visual benefits and quality-of-life impacts of Essilor4 AVA22 lenses prescribed using the AVA22 refraction protocol versus standard prescription methods. This research could influence future optometric care by exploring the clinical advantages of higher resolution refraction technology. Participants will wear two types of lenses in a crossover design. One group wears the Essilor4 AVA22 lenses for two weeks, then after a two-week break, wears standard lenses for two weeks. The other group follows the reverse order. Both lens types are prescribed using different refraction protocols: the AVA22 protocol for AVA lenses and the gold standard protocol for standard lenses. The study compares visual clarity, comfort, and satisfaction between these lenses. During the study, participants will undergo vision tests and complete questionnaires to evaluate binocular vision quality, refraction accuracy, and subjective vision experience. These assessments occur immediately after each lens-wearing period and throughout the approximately eight-week study. Researchers will monitor preferences for each lens type and measure various aspects of vision including visual acuity and contrast sensitivity. Participants must wear the assigned lenses at least six hours daily during the lens-wearing periods and attend scheduled visits.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • Signed consent form
  • Agree to attend all scheduled visits
  • Best-corrected visual acuity of 20/25 (0.10 logMAR) or better in each eye
  • Spherical equivalent refractive error between -10.00 and +10.00 diopters
  • Currently own wearable and functional eyeglasses
  • Agree to wear assigned frames for at least 14 days, 6 hours per day (42 hours per week)
  • No binocular vision issues
  • No cataract graded 2 or higher
  • For presbyopic group: age 35 to 70 years and adapted to progressive addition lenses
Not Eligible

You will not qualify if you...

  • Younger than 18 or older than 70 years
  • Do not wear spectacles at least 6 hours per day
  • Do not have a wearable pair of glasses with a prescription less than or equal to 2 years old
  • Currently or formerly licensed optometrist, optician, or ophthalmic technician trained in refraction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 8 weeks including washout

Participants are prescribed to wear two different types of lenses in a crossover design: AVA lenses and Standard lenses, each worn for 2 weeks. There is a 2-week washout period between wearing each type of lens.

3 visits (in-person) including baseline and after each lens period

Trial Site Locations

Total: 1 location

1

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

Bloomington, Indiana, United States, 47405

Actively Recruiting

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Research Team

P

Pete Kollbaum, Professor

D

Dawn Meyer, OD, FAAO

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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