Tolerance to Light for Patients Suffering From Keratitis

Not Applicable

Completed

• Conditions: Keratitis
• Interventions: Device: Light exposure

• Registration Number: NCT03586505
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study Start: 2018-07-03
• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-13
• Primary Completion: 2019-08-07
• Study Completion: 2019-08-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Light exposure	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Severity of the keratitis	At the inclusion	It is determined by slit lamp. The result is "severe" or "not severe"

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France