Tolerance to Light for Patients Suffering From Keratitis

Keratitis Clinical Trial

— EBLOUI  

Official title:

Tolerance to Light for Patients Suffering From Keratitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586505
• Other study ID #: 1708072
• Secondary ID: 2017-A03451-52
• Status: Completed
• Phase: N/A
• Start date: July 3, 2018
• Est. completion date: August 7, 2019

Study information

• Verified date: September 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 7, 2019
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratitis

Intervention

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

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	University of Saint-Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Light intensity	For each wavelength, the highest light intensity tolerated by the patient is measured (mWatts/cm² )	At the inclusion
Secondary	Severity of the keratitis	It is determined by slit lamp. The result is "severe" or "not severe"	At the inclusion