Ocular RosaceaMEIBO-ROSACEENCT03479853
Clinical, Meibographic and Interferometric Evaluation of Phlyctenular Keratitis in Children - MEIBO-ROSACEE
An observational study of Ocular Rosacea and Keratoconjunctivitis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The aim of this study is to describe the clinical, meibographic and interferometric manifestations of phlyctenular keratitis in children. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Ocular Rosacea, Keratoconjunctivitis, Meibomian Gland Dysfunction
- What is being tested?
- Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2018to 11 May 2020
- Phase
- Observational
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged between 2 and 16 : Cases, suffering from ocular or oculo-cutaneous rosacea and Witnesses without any present or past palpebral or meibomian disease
Who may be able to join
- Recruited from a specialized ophthalmologic consultation Rothschild Ophthalmologic Foundation, Paris, France.
- Cases : suffering from ocular or oculo-cutaneous rosacea
- Witnesses : without any present or past palpebral or meibomian disease
Who cannot join
- Unable to achieve the meibographic and interferometric examination (Lipiview)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to describe the clinical, meibographic and interferometric manifestations of phlyctenular keratitis in children.
Read the detailed description
The investigators are conducting a monocentric, transversal, epidemiologic study. 100 patients should be included: 50 children suffering from ocular rosacea, and 50 children with no palpebral or Meibomian disease. Witnesses will be matched on the age of the cases.
Patient and controls will undergo a classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, the child will go through a meibographic and interferometric evaluation of his two inferior eyelids. This evaluation is made by an optometrist with the Lipiview device, and lasts a few minutes.
- Being tested
- Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)
- Keywords
- Ocular Rosacea, Keratoconjunctivitis, Meibomian Gland, Interferometry, Child
- Medical subject headings
- Rosacea, Keratoconjunctivitis, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)Procedure or surgery
Classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, meibographic and interferometric evaluation of his two inferior eyelids with the Lipiview device.
| Study group | Role | What they receive |
|---|---|---|
| Cases : suffering from ocular or oculo-cutaneous rosacea | Classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, meibographic and interferometric evaluation of his two inferior eyelids with the Lipiview device. Receives: Procedure: Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device) | |
| Witnesses | Without any present or past palpebral meibomian Gland Dysfunction
Classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, meibographic and interferometric evaluation of his two inferior eyelids with the Lipiview device. Receives: Procedure: Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical severity
Clinical severity is determined with a composite score, by the presence of chalazia, corneal lesions, neovascularization, phlyctena, loss of vision, superficial keratitis, anterior and posterior keratitis, meibomitis, palpebral margin keratinization, lagophthalmos, long term use of azithromycin treatment, treatment by ciclosporin eyedrops, intense cutaneous or ocular symptoms, long time evolution of the disease.
Measured: Day of inclusion
Meibographic severity
The meibographic severity is determined by the level of Meibomian gland atrophy, data obtained with the Lipiview
Measured: Day of inclusion
Interferometric severity
The interferometric severity is evaluated by the thickness of the lipid layer tear film, data obtained with the Lipiview
Measured: Day of inclusion
Number of abortive blinks
Number of abortive blinks during the Lipiview exam
Measured: Day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start2 Apr 2018
- Primary completion12 Mar 2020
- Study completion11 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular RosaceaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Serge DOAN, MD, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479853
- Sponsor's protocol ID
- SDN_2017_26
- Acronym
- MEIBO-ROSACEE
- Status last verified
- May 2020
- First submitted
- 14 Mar 2018
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Meibographic and Interferometric Evaluation of Phlyctenular Keratitis in Children - MEIBO-ROSACEE
- ClinicalTrials.gov ID
- NCT03479853
- Acronym / sponsor ID
- MEIBO-ROSACEE / SDN_2017_26
- Keywords
- Ocular Rosacea, Keratoconjunctivitis, Meibomian Gland, Interferometry, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 27 Mar 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.
The aim of this study is to describe the clinical, meibographic and interferometric manifestations of phlyctenular keratitis in children.
Detailed description
The investigators are conducting a monocentric, transversal, epidemiologic study. 100 patients should be included: 50 children suffering from ocular rosacea, and 50 children with no palpebral or Meibomian disease. Witnesses will be matched on the age of the cases.
Patient and controls will undergo a classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, the child will go through a meibographic and interferometric evaluation of his two inferior eyelids. This evaluation is made by an optometrist with the Lipiview device, and lasts a few minutes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases : suffering from ocular or oculo-cutaneous rosacea | – | Procedure: Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)Classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, meibographic and interferometric evaluation of his two inferior eyelids with the Lipiview device. |
| Witnesses | – | Procedure: Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)Without any present or past palpebral meibomian Gland Dysfunction Classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, meibographic and interferometric evaluation of his two inferior eyelids with the Lipiview device. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged between 2 and 16 : Cases, suffering from ocular or oculo-cutaneous rosacea and Witnesses without any present or past palpebral or meibomian disease
Key inclusion criteria (3 listed)
- Recruited from a specialized ophthalmologic consultation Rothschild Ophthalmologic Foundation, Paris, France.
- Cases : suffering from ocular or oculo-cutaneous rosacea
- Witnesses : without any present or past palpebral or meibomian disease
Key exclusion criteria (1 listed)
- Unable to achieve the meibographic and interferometric examination (Lipiview)
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 |
|---|---|---|
| Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)Classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, meibographic and interferometric evaluation of his two inferior eyelids with the Lipiview device. | Procedure or surgery | Cases : suffering from ocular or oculo-cutaneous rosacea, Witnesses |
Primary outcome
Clinical severity
Time frame: Day of inclusion
Clinical severity is determined with a composite score, by the presence of chalazia, corneal lesions, neovascularization, phlyctena, loss of vision, superficial keratitis, anterior and posterior keratitis, meibomitis, palpebral margin keratinization, lagophthalmos, long term use of azithromycin treatment, treatment by ciclosporin eyedrops, intense cutaneous or ocular symptoms, long time evolution of the disease.
Meibographic severity
Time frame: Day of inclusion
The meibographic severity is determined by the level of Meibomian gland atrophy, data obtained with the Lipiview
Interferometric severity
Time frame: Day of inclusion
The interferometric severity is evaluated by the thickness of the lipid layer tear film, data obtained with the Lipiview
Number of abortive blinks
Time frame: Day of inclusion
Number of abortive blinks during the Lipiview exam
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 13 May 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Ocular Rosacea
Enrolling by invitationPhase 2
Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)
Ocular Rosacea
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.
Serge DOAN, MD principal investigator
Fondation Ophtalmologique A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Rosacea and Keratoconjunctivitis, run by Fondation Ophtalmologique Adolphe de Rothschild 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 1 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 13 May 2020. 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?
Clinical severity (time frame: Day of inclusion). The study lists 4 primary outcomes in all. 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 13 May 2020.