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Observational Study on the Efficacy and Tolerance of EYEBRID Lenses

Sponsor
University Hospital, Caen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05036954
Collaborator
(none)
60
Enrollment
1
Location
10
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: EyeBrid Excel hybrid lenses

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study on the Efficacy and Tolerance of EYEBRID Lenses
Anticipated Study Start Date :
Sep 30, 2021
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

Arm Intervention/Treatment
no arm

Device: EyeBrid Excel hybrid lenses
new lenses

Outcome Measures

Primary Outcome Measures

  1. tolerance assesment [3 month]

    scale of discomfort when using contact lenses

Secondary Outcome Measures

  1. Improvement of visual acuity [3 month]

    measurement of visual acuity by the ETDRS charts

  2. Assessment and quantification of complications [3 month]

    note the number of abscesses

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Caen University Hospital Caen France 14033

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT05036954
Other Study ID Numbers:
  • 21-0045
First Posted:
Sep 8, 2021
Last Update Posted:
Sep 8, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 8, 2021