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)
30
Enrollment
1
Location
1
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

  1. Light intensity [At the inclusion]

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

Secondary Outcome Measures

  1. 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:
No
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

SiteCityStateCountryPostal Code
1CHU de Saint-EtienneSaint-ÉtienneFrance42000

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:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 17, 2019