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Observational Study on the Efficacy and Tolerance of EYEBRID Lenses | Clinical Trials | Clareo Health

UNKNOWN

Observational Study on the Efficacy and Tolerance of EYEBRID Lenses

NCT05036954•University Hospital, Caen

Summary

Technical advances in lenses are continuous and materials are improved. We provide a prospective longitudinal observational study evaluating the efficacy and safety of new EyeBrid Excel hybrid lenses (LCS) in the treatment of severe ametropia and for patients with corneal irregularities. This study should include 60 patients for a period of three months. The aim of this work is to assess the improvement in the best corrected visual acuity and the good tolerance of this lens.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•o Wear rigid lenses and complain about their lenses (discomfort, loss, poor vision) or
•* Wear rigid lenses and have objective intolerances (damage to surfaces related to rigid lenses) or
•* Are new wearers of lenses and presenting a strong ametropia (Strong myopia from -5.00 to -30.00d, strong hyperopia from + 4.50d to + 30.00d, strong astigmatism from 2.50d to 12.00d), with or without presbyopia (Addition of 0.75d to 3.50d)
•Any patient diagnosed with Keratoconus stages 1 to 3.
•Be affiliated to the social security system

Exclusion Criteria

•Patient with contraindications to wearing contact lenses
•Pregnant or breastfeeding woman
•Any minor or over 80 years old
•Any infection, inflammation or abnormality of the anterior segments
•Progressive ocular disorder of the anterior segments for which the wearing of contact lenses would be discouraged;
•Use of systemic or ocular treatment products for which the wearing of contact lenses would be discouraged;
•History of any herpetic keratitis;
•History of any refractive surgery or any irregular cornea (except in cases where the contact lenses examined may be worn by a subject with an irregular cornea, suffering from keratoconus or having undergone refractive surgery);
•Slit lamp observations of greater than grade 1 gravity;
•Vascularization of the cornea with a penetration greater than 1 mm;
+2 more criteria

Locations (1)

Caen University Hospital

Caen, France

Key Dates

Start Date

September 30, 2021

Primary Completion Date

November 30, 2021

Completion Date

July 30, 2022

Last Updated

September 8, 2021

Enrollment

ESTIMATED participants

Conditions

Contact Lens Complication

Interventions

EyeBrid Excel hybrid lenses

DEVICE

Contacts

Jean-Claude Quintyn, MD, PhD

CONTACT

00 33 2 31 06 46 30 quintyn-jc@chu-caen.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Observational Study on the Efficacy and Tolerance of EYEBRID Lenses

Inclusion Criteria

Exclusion Criteria

Efficacy of "Aquoral Lipo" Artificial Tears in Contact Lens Wearers With Discomfort

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