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OpenTrials
Completed

NCT Number: NCT03586505

Tolerance to Light for Patients Suffering From Keratitis

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.

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Key information

Conditions

Keratitis Corneal Diseases Eye Diseases Eye Infections Infections Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Photophobia Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Light exposure

Device

The 6 lights used randomly are :

  • 482nm =standard blue light illumination,
  • 650nm,
  • 675nm,
  • 700nm,
  • 750nm
  • 800nm

Primary outcomes

  1. Light intensity

    Time frame: At the inclusion

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

Secondary outcomes

  1. Severity of the keratitis

    Time frame: At the inclusion

    It is determined by slit lamp. The result is "severe" or "not severe"

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • University of Saint-Etienne

Registry information

Acronym: EBLOUI

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 13, 2018
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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