EBLOUI: Tolerance to Light for Patients Suffering From Keratitis

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT03586505

Collaborator

University of Saint-Etienne (Other)

Enrollment

Location

Arm

13.1

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In order to develop an innovative device to study infectious keratitis, we need to illuminate the cornea of patients suffering from an infectious keratitis with red or near-infrared light. Because of technical reasons the shortest possible wavelength (red) presents advantages.

Condition or Disease	Intervention/Treatment	Phase
Keratitis	Device: Light exposure	N/A

Detailed Description

The aim of this preliminary study is to measure the maximal intensity tolerated during illumination with 6 wavelength corresponding : 2 red, 2 far red and 1 near infrared lights in order to determine the shortest wavelength well tolerated by patients, in comparison with the standard blue light illumination.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Each patient is its own controlEach patient is its own control

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Tolerance to Light for Patients Suffering From Keratitis

Actual Study Start Date :

Jul 3, 2018

Actual Primary Completion Date :

Aug 7, 2019

Actual Study Completion Date :

Aug 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Light exposure The keratitis eye of the patient is exposed to 6 lights with increasing intensity according to a constant speed. The patients switch off the light when the discomfort is too elevated	Device: Light exposure The 6 lights used randomly are : 482nm =standard blue light illumination, 650nm, 675nm, 700nm, 750nm 800nm

Arm

Intervention/Treatment

Experimental: Light exposure

The keratitis eye of the patient is exposed to 6 lights with increasing intensity according to a constant speed. The patients switch off the light when the discomfort is too elevated

Device: Light exposure

The 6 lights used randomly are : 482nm =standard blue light illumination, 650nm, 675nm, 700nm, 750nm 800nm

Outcome Measures

Primary Outcome Measures

Light intensity [At the inclusion]
For each wavelength, the highest light intensity tolerated by the patient is measured (mWatts/cm² )

Secondary Outcome Measures

Severity of the keratitis [At the inclusion]
It is determined by slit lamp. The result is "severe" or "not severe"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Social security insurance
Suspected infectious keratitis (clinically defined. No lab testing required)
Signed informed consent

Exclusion Criteria:

Major Blepharospasm
Aphakia (absence of lens)
Pregnant woman
Nursing mother

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Saint-Etienne	Saint-Étienne		France	42000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne
University of Saint-Etienne

Investigators

Principal Investigator: Gilles THURET, MD PhD, CHU de Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT03586505

Other Study ID Numbers:

1708072
2017-A03451-52

First Posted:

Jul 13, 2018

Last Update Posted:

Sep 17, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

Additional relevant MeSH terms:

Keratitis

Study Results

No Results Posted as of Sep 17, 2019