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

NCT07168564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-06-09

No results posted yet for this 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.

Conditions

  • Ametropia
  • Refractive Error

Interventions

DEVICE

AVA lenses

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

DEVICE

Standard lenses

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

Sponsors & Collaborators

  • Essilor International

    lead INDUSTRY

Principal Investigators

  • Pete Kollbaum, Professor · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-22
Primary Completion
2026-05-28
Completion
2026-05-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07168564 on ClinicalTrials.gov