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Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia

NCT05326607 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-04-13

No results posted yet for this study

Summary

This study is a pilot clinical investigation of adaptive eyeglasses for the correction of presbyopia. The goal of this clinical investigation is to assess IMD safety and to obtain patient feedback on the usefulness of the Laclarée eyeglasses, through subjective clinical measures and qualitative evaluations. This is an exploratory investigation.

Conditions

Interventions

DEVICE

Prototype of adaptive eyeglasses

The tested investigational medical device is a prototype of semi-integrated eyeglasses.

DEVICE

Comparator

The comparator is either a pair of progressive lenses that provide clear vision at both distance and near vision, either, for wearers who have rejected progressive glasses, an alternative solution providing clear vision at both distance and near vision which can consist of bifocal glasses, multifocal or monovision lenses, multiple pairs of glasses or one pair for cases of emmetropia.

Sponsors & Collaborators

  • Iris Pharma

    collaborator INDUSTRY

  • Laclaree

    lead INDUSTRY

Principal Investigators

  • Bruno BERGE, PhD · SPONSOR: LACLAREE

  • Jessica JAROSZ, PhD · SPONSOR: LACLAREE

  • Philippe GAIN, Prof. · CHU SAINT-ETIENNE

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2022-01-27
Completion
2022-01-27

Countries

  • France

Study Locations

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Entities

Diseases

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 NCT05326607 on ClinicalTrials.gov