Tolerance to Light for Patients Suffering From Keratitis

NCT ID: NCT03586505

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-03

Study Completion Date

2019-08-07

Brief Summary

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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

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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.

Conditions

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Keratitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each patient is its own control
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Light exposure

Intervention Type DEVICE

The 6 lights used randomly are :

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

Interventions

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Light exposure

The 6 lights used randomly are :

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saint-Etienne

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles THURET, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

References

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Courrier E, Lambert V, Renault D, Garcin T, Moine B, Herbepin P, Thuret G, Gain P. Tolerance to Light of Patients Suffering From Infectious Keratitis. Cornea. 2021 Jan;40(1):5-11. doi: 10.1097/ICO.0000000000002516.

Reference Type DERIVED
PMID: 33038155 (View on PubMed)

Other Identifiers

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2017-A03451-52

Identifier Type: OTHER

Identifier Source: secondary_id

1708072

Identifier Type: -

Identifier Source: org_study_id

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