Corneal DiseaseINNOV-EYENCT02386774
Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa
A study testing Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml, Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig) and microangiography in people with Corneal Disease and Blepharitis, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
In vivo confocal microscopy (IVCM) used in tertiary care ophthalmology centers is performed with two reflectance microscopes attached on a mounting with limited movement along the XYZ axes. Consequently, ocular diseases in the central area have been described (mostly cornea and adjacent conjunctiva). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Disease, Blepharitis, Lacrimal Apparatus Diseases
- What is being tested?
- Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml, Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig) and microangiography
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Mar 2016to 28 Sep 2020
- 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
- Presenting with an ocular or ocular adnexa disease (infectious keratitis, stromal dystrophy, corneal surgery, ocular surface toxicity of eyedrops, cornea-conjunctival tumors, chronic blepharitis, eyelid tumors, diseases of the proximal lachrymal tract).
- For the microangiography: diabetic patients
Who cannot join
- Allergy to one of the 3 dyes (fluorescein, indocyanine green, rose Bengal)
- Pregnancy and breast feeding
- Predicable impossible follow up
- For patient volunteer for intravenous injections: beta blockers
Trial locations and contacts
2 sites in 1 country.
France2 sites
Chu de Saint Etienne
Saint-Etienne, Dermatology, 42055
Chu de Saint Etienne
Saint-Etienne, Ophtalmology, 42055
About this study
Official title: Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa : Study of a Handheld in Vivo Confocal Microscope and of a Fluorescent in Vivo Confocal Microscope
In vivo confocal microscopy (IVCM) used in tertiary care ophthalmology centers is performed with two reflectance microscopes attached on a mounting with limited movement along the XYZ axes. Consequently, ocular diseases in the central area have been described (mostly cornea and adjacent conjunctiva). Two dermatology IVCM (an handheld small IVCM and a multifluorescent one) present significant innovations that the investigators want to assess in ophthalmology for the diagnosis of conjunctiva, cornea, eyelid and lachrymal tract diseases. The handheld IVCM have unlimited degrees of freedom and a small diameter objective. It could dramatically increase the area accessible to IVCM (whole conjunctiva, eyelids, proximal lachrymal tract) (part 1 of the present study). The fluorescent IVCM allows the use of a wide range of fluorescent markers liable to increase the specificity of the diagnosis by revealing staining patterns corresponding to a specific disease and not to others (part 2 of the study)
- Conditions
- Corneal Disease, Blepharitis, Lacrimal Apparatus Diseases
- Being tested
- Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml, Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig), microangiography
- Keywords
- In vivo confocal microscopy, corneal disease, Blepharitis, Lacrimal Apparatus Diseases, Microscopy, Confocal
- Medical subject headings
- Corneal Diseases, Blepharitis, Lacrimal Apparatus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 mlDevice
used anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml
Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)Device
used for Multifluorescence IVCM
- anesthesic eyedrop : oxybuprocaïne (1,6 mg/0,4 ml)
- Fluorescein 0,5%, Rose Bengal , Infracyanine
microangiographyProcedure or surgery
realization of the microangiography with intravenous injection of fluoresceine and indocyanine green.
| Study group | Role | What they receive |
|---|---|---|
| an ocular or ocular adnexa disease | Other | patient presenting with an ocular or ocular adnexa disease in the Dermatology or Ophthalmology ward. Receives: Device: Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml; Device: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig); Procedure: microangiography |
| diabetic patients | Other | Not described Receives: Device: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig); Procedure: microangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases
Measured: 1 year
Secondary outcomes (7)
handheld IVCM : sensitivity (se) and specificity (sp) in each 8 subgroups of diseases
Measured: 1 year
handheld IVCM : positive and negative predictive values in each 8 subgroups of diseases
Measured: 1 year
handheld IVCM : AUC of the ROC curve in each 8 subgroups of diseases
Measured: 1 year
handheld IVCM : factors influencing image quality
using a scale to 3 levels (2 : optic diagnosis ; 1 : presence of artifacts but possible optic diagnosis ; 0 :impossible optic diagnosis)
Measured: 1 year
handheld IVCM : determining the limits of the tumor
(in the particular case of tumors requiring surgery)
Measured: 1 year
fluorescence : staining patterns obtained for each disease group
Measured: 1 year
fluorescence : characteristics of the micro-angiography
characteristics of the conjunctival vessels in normal and diabetic patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study start21 Mar 2016
- Primary completion28 Sep 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DiseaseStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles THURET, MD PhD, Principal investigator, CHU de St Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386774
- Sponsor's protocol ID
- 1208180
- Other IDs
- 2015-A00331-48
- Acronym
- INNOV-EYE
- Status last verified
- Jan 2024
- First submitted
- 20 Feb 2015
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa : Study of a Handheld in Vivo Confocal Microscope and of a Fluorescent in Vivo Confocal Microscope
- ClinicalTrials.gov ID
- NCT02386774
- Acronym / sponsor ID
- INNOV-EYE / 1208180
- Conditions
- Corneal Disease, Blepharitis, Lacrimal Apparatus Diseases
- Keywords
- In vivo confocal microscopy, corneal disease, Blepharitis, Lacrimal Apparatus Diseases, Microscopy, Confocal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 21 Mar 2016 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 12 Mar 2015 (estimated)
- 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 vivo confocal microscopy (IVCM) used in tertiary care ophthalmology centers is performed with two reflectance microscopes attached on a mounting with limited movement along the XYZ axes. Consequently, ocular diseases in the central area have been described (mostly cornea and adjacent conjunctiva). Two dermatology IVCM (an handheld small IVCM and a multifluorescent one) present significant innovations that the investigators want to assess in ophthalmology for the diagnosis of conjunctiva, cornea, eyelid and lachrymal tract diseases. The handheld IVCM have unlimited degrees of freedom and a small diameter objective. It could dramatically increase the area accessible to IVCM (whole conjunctiva, eyelids, proximal lachrymal tract) (part 1 of the present study). The fluorescent IVCM allows the use of a wide range of fluorescent markers liable to increase the specificity of the diagnosis by revealing staining patterns corresponding to a specific disease and not to others (part 2 of the study)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| an ocular or ocular adnexa disease | Other | Device: Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml, Device: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig), Procedure: microangiographypatient presenting with an ocular or ocular adnexa disease in the Dermatology or Ophthalmology ward. |
| diabetic patients | Other | Device: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig), Procedure: microangiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presenting with an ocular or ocular adnexa disease (infectious keratitis, stromal dystrophy, corneal surgery, ocular surface toxicity of eyedrops, cornea-conjunctival tumors, chronic blepharitis, eyelid tumors, diseases of the proximal lachrymal tract).
- For the microangiography: diabetic patients
Key exclusion criteria (4 listed)
- Allergy to one of the 3 dyes (fluorescein, indocyanine green, rose Bengal)
- Pregnancy and breast feeding
- Predicable impossible follow up
- For patient volunteer for intravenous injections: beta blockers
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 |
|---|---|---|
| Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 mlused anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml | Device | an ocular or ocular adnexa disease |
| Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)used for Multifluorescence IVCM * anesthesic eyedrop : oxybuprocaïne (1,6 mg/0,4 ml) * Fluorescein 0,5%, Rose Bengal , Infracyanine | Device | an ocular or ocular adnexa disease, diabetic patients |
| microangiographyrealization of the microangiography with intravenous injection of fluoresceine and indocyanine green. | Procedure or surgery | an ocular or ocular adnexa disease, diabetic patients |
Primary outcome
Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases
Time frame: 1 year
7 secondary outcomes
handheld IVCM : sensitivity (se) and specificity (sp) in each 8 subgroups of diseases
Time frame: 1 year
handheld IVCM : positive and negative predictive values in each 8 subgroups of diseases
Time frame: 1 year
handheld IVCM : AUC of the ROC curve in each 8 subgroups of diseases
Time frame: 1 year
handheld IVCM : factors influencing image quality
Time frame: 1 year
handheld IVCM : determining the limits of the tumor
Time frame: 1 year
fluorescence : staining patterns obtained for each disease group
Time frame: 1 year
fluorescence : characteristics of the micro-angiography
Time frame: 1 year
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 8 Jan 2024.
- 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 St Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml, Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig) and microangiography in people with Corneal Disease and Blepharitis, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites 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 2 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 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2024.