Tolerance to Light for Patients Suffering From Keratitis (EBLOUI)

September 16, 2019 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France, 42000
        • CHU de SAINT-ETIENNE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Light intensity
Time Frame: At the inclusion
For each wavelength, the highest light intensity tolerated by the patient is measured (mWatts/cm² )
At the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of the keratitis
Time Frame: At the inclusion
It is determined by slit lamp. The result is "severe" or "not severe"
At the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

University of Saint-Etienne

Investigators

  • Principal Investigator: Gilles THURET, MD PhD, CHU de SAINT-ETIENNE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2018

Primary Completion (Actual)

August 7, 2019

Study Completion (Actual)

August 7, 2019

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1708072
  • 2017-A03451-52 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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