Ocular Surface in Patients With Soft Contact Lenses

NCT04244643 | Completed

• 1 other identifier: IRBN922019/CHUSTE
• Study Type: observational
• Target: 524
• Locations: 1 country
• Sites: 12

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.

Conditions

Ocular Surface

Keywords

contact lenses

Outcome Measures

Primary Outcomes (1)

• eye surface condition

  presence or not : dry eye, allergies, blepharitis, corneal abscess, corneal ulceration, corneal neovascularization, chronic inflammatory conjunctivitis and others

  baseline

Secondary Outcomes (5)

• refraction

  baseline

• Ocular Surface Disease Index score

  baseline

• non-invasive tear break-up time

  baseline

• interferometry

  baseline

• tears meniscus height

  baseline

Study Arms (1)

Patients with soft contact lenses

Other: data collection

Interventions

data collection 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

Patients with soft contact lenses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with soft contact lenses

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Société Française des Ophtalmologistes Adaptateurs de Lentilles de Contact: collaborator

Study Sites (12)

Cabinet médico-chirurgical de l'Alcazar

Beausoleil, 06240, France

Location

Cabinet du Dr Virginie MADARIAGA

Blagnac, 31700, France

Location

Point Vision Bordeaux

Bordeaux, 33000, France

Location

Cabinet du Dr Françoise LE CHERPIE

Draguignan, 83300, France

Location

Cabinet du Dr Hélène Bertrand

Lille, 59800, France

Location

Centre ophtalmologique Saint-Paul

Paris, 75004, France

Location

Point Vision Paris Royale

Paris, 75008, France

Location

Centre hospitalier national d'ophtalmologie des Quinze-Vingts

Paris, 75012, France

Location

Cabinet du Dr Cyrille TEMSTET

Paris, 75017, France

Location

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

Point Vision Nice - St Laurent du Var

Saint-Laurent-du-Var, 06700, France

Location

Clinique St Jean Languedoc

Toulouse, 31400, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marie Caroline TRONE

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 28, 2020
• Study Start: December 18, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)