Skip to main content
OpenTrials
Completed

NCT Number: NCT04244643

Ocular Surface in Patients With Soft Contact Lenses

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ocular Surface

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet médico-chirurgical de l'Alcazar, Beausoleil, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. eye surface condition

    Time frame: baseline

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

Secondary outcomes

  1. refraction

    Time frame: baseline

    measured with vision tests

  2. Ocular Surface Disease Index score

    Time frame: 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.

  3. non-invasive tear break-up time

    Time frame: baseline

    with LACRYDIAG

  4. interferometry

    Time frame: baseline

    with LACRYDIAG. Qualitative & quantitative analysis of the lipid layer.

  5. tears meniscus height

    Time frame: baseline

    with LACRYDIAG

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Société Française des Ophtalmologistes Adaptateurs de Lentilles de Contact

Registry information

Acronym: E2LC

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2020
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.