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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05036954
Other study ID # 21-0045
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 30, 2021
Est. completion date July 30, 2022

Study information

Verified date July 2021
Source University Hospital, Caen
Contact Jean-Claude Quintyn, MD, PhD
Phone 00 33 2 31 06 46 30
Email quintyn-jc@chu-caen.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date July 30, 2022
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
EyeBrid Excel hybrid lenses
new lenses

Locations

Country Name City State
France Caen University Hospital Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary tolerance assesment scale of discomfort when using contact lenses 3 month
Secondary Improvement of visual acuity measurement of visual acuity by the ETDRS charts 3 month
Secondary Assessment and quantification of complications note the number of abscesses 3 month
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