Ocular Surface in Patients With Soft Contact Lenses

Completed

• Conditions: Ocular Surface
• Interventions: Other: data collection

• Registration Number: NCT04244643
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

Not available

Study Timeline

• Study Start: 2019-12-18
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 524

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with soft contact lenses	data collection	-

Primary Outcome Measures

Name	Time	Method
eye surface condition	baseline	presence or not : dry eye, allergies, blepharitis, corneal abscess, corneal ulceration, corneal neovascularization, chronic inflammatory conjunctivitis and others

Secondary Outcome Measures

Name	Time	Method
interferometry	baseline	with LACRYDIAG. Qualitative \& quantitative analysis of the lipid layer.
Ocular Surface Disease Index score	baseline	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.
tears meniscus height	baseline	with LACRYDIAG
refraction	baseline	measured with vision tests
non-invasive tear break-up time	baseline	with LACRYDIAG

Trial Locations

Locations (12)

Cabinet du Dr Virginie MADARIAGA; 🇫🇷 Blagnac, France

Cabinet du Dr Cyrille TEMSTET; 🇫🇷 Paris, France

CHU de Saint Etienne; 🇫🇷 Saint Etienne, France

Cabinet médico-chirurgical de l'Alcazar; 🇫🇷 Beausoleil, France

Clinique St Jean Languedoc; 🇫🇷 Toulouse, France

Cabinet du Dr Françoise LE CHERPIE; 🇫🇷 Draguignan, France

Point Vision Nice - St Laurent du Var; 🇫🇷 Saint-Laurent-du-Var, France

Centre ophtalmologique Saint-Paul; 🇫🇷 Paris, France

Point Vision Bordeaux; 🇫🇷 Bordeaux, France

Cabinet du Dr Hélène Bertrand; 🇫🇷 Lille, France

Centre hospitalier national d'ophtalmologie des Quinze-Vingts; 🇫🇷 Paris, France

Point Vision Paris Royale; 🇫🇷 Paris, France