NCT03586505

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

July 3, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2019

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

July 3, 2018

Last Update Submit

September 16, 2019

Conditions

Keratitis

Keywords

KeratitisEye InfectionPhotophobiaRed lightInfrared light

Outcome Measures

Primary Outcomes (1)

  • Light intensity

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

    At the inclusion

Secondary Outcomes (1)

  • Severity of the keratitis

    At the inclusion

Study Arms (1)

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

Device: Light exposure

Interventions

Light exposureDEVICE

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

Light exposure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Social security insurance
  • Suspected infectious keratitis (clinically defined. No lab testing required)
  • Signed informed consent

You may not qualify if:

  • Major Blepharospasm
  • Aphakia (absence of lens)
  • Pregnant woman
  • Nursing mother

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

Related Publications (1)

  • 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.

    PMID: 33038155DERIVED

MeSH Terms

Conditions

KeratitisEye InfectionsPhotophobia

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesInfectionsVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gilles THURET, MD PhD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Each patient is its own control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2018

First Posted

July 13, 2018

Study Start

July 3, 2018

Primary Completion

August 7, 2019

Study Completion

August 7, 2019

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)