Interest of Eye Movement Measurements in the Comprehension of Dry Eyes Symptoms (BOSO)

Interest of Eye Movement Measurements in the Comprehension of Dry Eyes Symptoms (BOSO)

Dry eye syndrome is a benign situation however its impact on patient's quality of live and on health system is not trivial. One problem is the lack of correlation between patient's symptoms and physical sign observed on slit lamp examination. Eye blinking is a parameter of increased interest in this pathology particularly its frequency. To date no treatment of dry eye syndrome has a proven impact on eye blinking frequency. However recording of blinks has mostly been performed on short duration (3 to 5 minutes) and the distribution of intervals between 2 blinks is not gaussian but exponential. In this study, it is proposed to use modern eye-movement recorder to measure the blink frequency on longer duration (12 minutes) while reading on a screen computer and during a face-to-face interview before and after treatment of meibomian gland dysfunction responsible of moderate to severe dry eye syndrome.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Blinking
• Intervention / Treatment: Device: Infrared oculography

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation Ophtalmologique Adolphe de Rothschild (FOR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to severe dry eye syndrome from meibomian gland dysfunction

Description

Inclusion Criteria:

• Moderate to severe dry eye syndrome (Ocular Surface Disease Index> 30) following a meibomian gland dysfunction
• Not yet properly treated for a meibomian gland dysfunction

Exclusion Criteria:

• History of other ophthalmological or neurological disease
• Pregnant or breastfeeding women
• Patient under 18 years old
• Patient under legal protection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dry eye syndrome; Meibomian gland dysfunction responsible of moderate to severe dry eye syndrome	Device: Infrared oculography; The infrared oculography provides binocular recordings and allows simultaneous measurement of horizontal and vertical eye movements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration between 2 blinks	Assessment by infrared oculography while the patient is reading on a computer screen and during a face-to-face interview	2 months after treatment

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2014
• Primary Completion (ACTUAL): October 30, 2019
• Study Completion (ACTUAL): October 30, 2019

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (ESTIMATE): August 1, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: CLL_2013-16