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Clinical Trials/NCT03586505
NCT03586505CompletedNot Applicable

Tolerance to Light for Patients Suffering From Keratitis

Centre Hospitalier Universitaire de Saint Etienne2 sites in 1 country30 target enrollmentStarted: July 3, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Light intensity

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Light exposure

Experimental

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: Light exposure (Device)

Outcomes

Primary Outcomes

Light intensity

Time Frame: At the inclusion

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

Secondary Outcomes

  • Severity of the keratitis(At the inclusion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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