Ocular Surface in Patients With Soft Contact Lenses (E2LC)

Contact lenses modify the structure of the tear film by biophysical and biochemical interactions. These changes may explain more common dry eye symptoms and may sometimes cause lens failure or discontinuation.

In recent years, the investigators have various objective non-invasive methods of tear film evaluation such as the non-invasive break up time, interferometry, and tears meniscus height. These measurements are performed in clinical practice during consultation by devices such as LACRYDIAG.

The improvement of lens comfort requires a better knowledge of the ocular surface in patients with contact lenses. But currently none of these objective parameters have been accurately described.

Therefore, the investigators would like to build a database to describe the different parameters of ocular surface in patients with soft contact lenses.

Study Overview

• Status: Completed
• Conditions: Ocular Surface
• Intervention / Treatment: Other: data collection

• Study Type: Observational
• Enrollment (Actual): 524

Contacts and Locations

Study Locations

• France
  • Beausoleil, France, 06240
    • Cabinet médico-chirurgical de l'Alcazar
  • Blagnac, France, 31700
    • Cabinet du Dr Virginie MADARIAGA
  • Bordeaux, France, 33000
    • Point Vision Bordeaux
  • Draguignan, France, 83300
    • Cabinet du Dr Françoise LE CHERPIE
  • Lille, France, 59800
    • Cabinet du Dr Hélène Bertrand
  • Paris, France, 75012
    • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
  • Paris, France, 75004
    • Centre ophtalmologique Saint-Paul
  • Paris, France, 75008
    • Point Vision Paris Royale
  • Paris, France, 75017
    • Cabinet du Dr Cyrille TEMSTET
  • Saint Etienne, France, 42055
    • CHU de Saint Etienne
  • Saint-Laurent-du-Var, France, 06700
    • Point Vision Nice - St Laurent du Var
  • Toulouse, France, 31400
    • Clinique St Jean Languedoc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with soft contact lenses

Description

Inclusion Criteria:

• Patients with soft contact lenses
• Patients with their contact lenses on the eyes at the time of the examination and having undergone a LACRYDIAG examination
• Only Right eye analyze

Exclusion Criteria:

• Patients with rigid contact lenses
• Patients not wearing their lenses at the time of the examination

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with soft contact lenses

Other: data collection; Data collected from patient records; Demographic data: date of birth, sex, city of birth; Contact lenses: laboratory, brand, model, wearing time before the exam, opening date of the blister, solution of contact lenses, material, renewal time; Refraction; Dry eye disease: Ocular Surface Disease Index (OSDI) score; LACRYDIAG data: Non-Invasive Break-Up Time (NIBUT), interferometry and tears meniscus height

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eye surface condition	presence or not : dry eye, allergies, blepharitis, corneal abscess, corneal ulceration, corneal neovascularization, chronic inflammatory conjunctivitis and others	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
refraction	measured with vision tests	baseline
Ocular Surface Disease Index score	is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The overall OSDI score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.	baseline
non-invasive tear break-up time	with LACRYDIAG	baseline
interferometry	with LACRYDIAG. Qualitative & quantitative analysis of the lipid layer.	baseline
tears meniscus height	with LACRYDIAG	baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Société Française des Ophtalmologistes Adaptateurs de Lentilles de Contact
• Investigators: Principal Investigator: Marie Caroline TRONE, CHU de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: contact lenses
• Other Study ID Numbers: IRBN922019/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No