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

Dry Eye Syndromes Clinical Trial

— BOSO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851654
• Other study ID #: CLL_2013-16
• Status: Completed
• Start date: November 5, 2014
• Est. completion date: October 30, 2019

Study information

• Verified date: December 2019
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blinking
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild (FOR)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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