Observational Study on the Efficacy and Tolerance of EYEBRID Lenses

• Conditions: Contact Lens Complication
• Interventions: Device: EyeBrid Excel hybrid lenses

• Registration Number: NCT05036954
• Lead Sponsor: University Hospital, Caen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-12
• Status Verified: 2021-07
• Study First Submitted QC: 2021-09-02
• Last Update Submitted: 2021-09-02
• Study First Posted: 2021-09-08
• Last Update Posted: 2021-09-08
• Study Start: 2021-09-30
• Primary Completion: 2021-11-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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;
• Case of pathological dry eye;
• When a subject has participated in a clinical trial on contact lenses or contact lens care products within the past 30 days.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
no arm	EyeBrid Excel hybrid lenses	-

Primary Outcome Measures

Name	Time	Method
tolerance assesment	3 month	scale of discomfort when using contact lenses

Secondary Outcome Measures

Name	Time	Method
Assessment and quantification of complications	3 month	note the number of abscesses
Improvement of visual acuity	3 month	measurement of visual acuity by the ETDRS charts

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France