Interest of Eye Movement Measurements in the Comprehension of Dry Eyes Symptoms

NCT02851654 | Completed

• 1 other identifier: CLL_2013-16
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Syndromes; Blinking

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Dry eye syndrome

Meibomian gland dysfunction responsible of moderate to severe dry eye syndrome

Device: Infrared oculography

Interventions

Infrared oculography DEVICE

The infrared oculography provides binocular recordings and allows simultaneous measurement of horizontal and vertical eye movements.

Dry eye syndrome

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 moderate to severe dry eye syndrome from meibomian gland dysfunction

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild (FOR)

Paris, 75019, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 1, 2016
• Study Start: November 5, 2014
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-12

Locations

FR (1)