Ocular Surface in Patients With Soft Contact Lenses

NCT ID: NCT04244643

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

524 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-18

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ocular Surface

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with soft contact lenses

data collection

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société Française des Ophtalmologistes Adaptateurs de Lentilles de Contact

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Caroline TRONE

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne

Locations

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Cabinet médico-chirurgical de l'Alcazar

Beausoleil, , France

Site Status

Cabinet du Dr Virginie MADARIAGA

Blagnac, , France

Site Status

Point Vision Bordeaux

Bordeaux, , France

Site Status

Cabinet du Dr Françoise LE CHERPIE

Draguignan, , France

Site Status

Cabinet du Dr Hélène Bertrand

Lille, , France

Site Status

Centre ophtalmologique Saint-Paul

Paris, , France

Site Status

Point Vision Paris Royale

Paris, , France

Site Status

Centre hospitalier national d'ophtalmologie des Quinze-Vingts

Paris, , France

Site Status

Cabinet du Dr Cyrille TEMSTET

Paris, , France

Site Status

CHU de Saint Etienne

Saint-Etienne, , France

Site Status

Point Vision Nice - St Laurent du Var

Saint-Laurent-du-Var, , France

Site Status

Clinique St Jean Languedoc

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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IRBN922019/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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