KeratitisEBLOUINCT03586505
Tolerance to Light for Patients Suffering From Keratitis
A study testing Light exposure in people with Keratitis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratitis
- What is being tested?
- Light exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2018to 7 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Social security insurance
- Suspected infectious keratitis (clinically defined. No lab testing required)
- Signed informed consent
Who cannot join
- Major Blepharospasm
- Aphakia (absence of lens)
- Pregnant woman
- Nursing mother
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Keratitis
- Being tested
- Light exposure
- Keywords
- Keratitis, Eye Infection, Photophobia, Red light, Infrared light
- Medical subject headings
- Keratitis, Eye Infections, Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light exposureDevice
The 6 lights used randomly are :
- 482nm =standard blue light illumination,
- 650nm,
- 675nm,
- 700nm,
- 750nm
- 800nm
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Light exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Light intensity
For each wavelength, the highest light intensity tolerated by the patient is measured (mWatts/cm² )
Measured: At the inclusion
Secondary outcomes (1)
Severity of the keratitis
It is determined by slit lamp. The result is "severe" or "not severe"
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start3 Jul 2018
- Primary completion7 Aug 2019
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeratitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each patient is its own control
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Saint-Etienne
- Responsible party
- Sponsor
- Investigators
- Gilles THURET, MD PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586505
- Sponsor's protocol ID
- 1708072
- Other IDs
- 2017-A03451-52
- Acronym
- EBLOUI
- Status last verified
- Sep 2019
- First submitted
- 3 Jul 2018
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33038155
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance to Light for Patients Suffering From Keratitis
- ClinicalTrials.gov ID
- NCT03586505
- Acronym / sponsor ID
- EBLOUI / 1708072
- Conditions
- Keratitis
- Keywords
- Keratitis, Eye Infection, Photophobia, Red light, Infrared light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- University of Saint-Etienne
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each patient is its own control
| Arm | Type | Receives |
|---|---|---|
| Light exposure | Experimental | Device: Light exposureThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Social security insurance
- Suspected infectious keratitis (clinically defined. No lab testing required)
- Signed informed consent
Key exclusion criteria (4 listed)
- Major Blepharospasm
- Aphakia (absence of lens)
- Pregnant woman
- Nursing mother
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light exposureThe 6 lights used randomly are : * 482nm =standard blue light illumination, * 650nm, * 675nm, * 700nm, * 750nm * 800nm | Device | Light exposure |
Primary outcome
Light intensity
Time frame: At the inclusion
For each wavelength, the highest light intensity tolerated by the patient is measured (mWatts/cm² )
1 secondary outcome
Severity of the keratitis
Time frame: At the inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Derived from this study: PubMed 33038155Courrier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles THURET, MD PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light exposure in people with Keratitis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Light intensity (time frame: At the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03586505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.