Analysis of the Diagnostic Performance of LacryDiag, a New Analyzer of the Ocular Surface in the Dry Eye

NACompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 14, 2019

Primary Completion Date

August 27, 2020

Study Completion Date

August 27, 2020

Conditions
Dry Eye
Interventions
DIAGNOSTIC_TEST

Time #1: Non Invasive Break-Up Time (NIBUT)

"A LacryDiag examination without dye will be realized. All measurements are made without contact. It's calculates the Non Invasive Break-Up Time (NIBUT), Tear Meniscus (TM) height (in millimeters) and number of Meibomian Gland.~These are different pictures taken with LacryDiag and analyzed."

DIAGNOSTIC_TEST

Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score

"The MicroInstillation of fluorescein Break-Up Time (MIBUT) will be calculated by manual MIBUT and LacryDiag MIBUT.~The Oxford score will be calculated. It's used to clinically determine the severity of dry eyes with minimum score at 0 (none) and maximum score at 5 (very severity)."

DIAGNOSTIC_TEST

Time #3: Standard Break-Up Time (SBUT)

The Standard Break-Up Time (SBUT) with fluorescein macroinstillation will be calculated by manual SBUT and LacryDiag SBUT.

DIAGNOSTIC_TEST

Time #4: Schirmer test

The Schirmer test will be performed. It consists of applying the end of a small strip of blotting paper behind the lower eyelid and examining the strip after 5 minutes.

DIAGNOSTIC_TEST

Satisfaction questionnaire to the patient

A satisfaction questionnaire to the patient will be completed at the end of the participation at the study.

Trial Locations (1)

Unknown

Chu Saint-Etienne, Saint-Etienne

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Saint Etienne

OTHER

NCT04093037 - Analysis of the Diagnostic Performance of LacryDiag, a New Analyzer of the Ocular Surface in the Dry Eye | Biotech Hunter | Biotech Hunter