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Ocular Surface in Patients With Soft Contact Lenses

Ocular Surface in Patients With Soft Contact Lenses

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04244643
Acronym
E2LC
Enrollment
524
Registered
2020-01-28
Start date
2019-12-18
Completion date
2019-12-31
Last updated
2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Surface

Keywords

contact lenses

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.

Interventions

OTHERdata 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

Sponsors

Société Française des Ophtalmologistes Adaptateurs de Lentilles de Contact
CollaboratorUNKNOWN
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
eye surface conditionbaselinepresence or not : dry eye, allergies, blepharitis, corneal abscess, corneal ulceration, corneal neovascularization, chronic inflammatory conjunctivitis and others

Secondary

MeasureTime frameDescription
refractionbaselinemeasured with vision tests
Ocular Surface Disease Index scorebaselineis 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.
non-invasive tear break-up timebaselinewith LACRYDIAG
interferometrybaselinewith LACRYDIAG. Qualitative & quantitative analysis of the lipid layer.
tears meniscus heightbaselinewith LACRYDIAG

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026