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Tolerance to Light for Patients Suffering From Keratitis (EBLOUI)

Primary Purpose

Keratitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Light exposure
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Keratitis focused on measuring Keratitis, Eye Infection, Photophobia, Red light, Infrared light

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Light exposure

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 3, 2018
Last Updated
September 16, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
University of Saint-Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT03586505
Brief Title
Tolerance to Light for Patients Suffering From Keratitis
Acronym
EBLOUI
Official Title
Tolerance to Light for Patients Suffering From Keratitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
August 7, 2019 (Actual)
Study Completion Date
August 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
University of Saint-Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratitis
Keywords
Keratitis, Eye Infection, Photophobia, Red light, Infrared light

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each patient is its own control
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Light exposure
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Light exposure
Intervention Description
The 6 lights used randomly are : 482nm =standard blue light illumination, 650nm, 675nm, 700nm, 750nm 800nm
Primary Outcome Measure Information:
Title
Light intensity
Description
For each wavelength, the highest light intensity tolerated by the patient is measured (mWatts/cm² )
Time Frame
At the inclusion
Secondary Outcome Measure Information:
Title
Severity of the keratitis
Description
It is determined by slit lamp. The result is "severe" or "not severe"
Time Frame
At the inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles THURET, MD PhD
Organizational Affiliation
CHU de Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33038155
Citation
Courrier E, Lambert V, Renault D, Garcin T, Moine B, Herbepin P, Thuret G, Gain P. Tolerance to Light of Patients Suffering From Infectious Keratitis. Cornea. 2021 Jan;40(1):5-11. doi: 10.1097/ICO.0000000000002516.
Results Reference
derived

Learn more about this trial

Tolerance to Light for Patients Suffering From Keratitis

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