Mast Cell Activation DiseaseNCT04978740
Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)
A study testing Ophthalmological examination in people with Mast Cell Activation Disease and Mast Cell Activation Syndrome, run by Poitiers University Hospital at 1 site in France.
Trial summary
Mastocytosis is a rare condition characterized by an accumulation of mast cell cells in one or more organs such as the liver, bone marrow, spleen and intestines. Its prevalence in the general population is 1 in 10,000. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mast Cell Activation Disease, Mast Cell Activation Syndrome, Mast Cell Disease
- What is being tested?
- Ophthalmological examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2021to 3 Sep 2021
- 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
- Have a diagnosis of mastocytosis
- Male or female, 18 years of age and over
- Ability to understand and provide written informed consent.
Who cannot join
- Disorders that do not allow good visualization of the posterior pole (cataract, intravitreal hemorrhage)
- Patients with another ocular pathology that may bias the results (corneal dystrophy, dysthyroid orbitopathy, retinal pathologies)
- History of refractive surgery
Trial locations and contacts
1 site in 1 country.
About this study
Mastocytosis is a rare condition characterized by an accumulation of mast cell cells in one or more organs such as the liver, bone marrow, spleen and intestines. Its prevalence in the general population is 1 in 10,000.
This pathology is due to the proliferation of a mast cell clone and the excessive release of inflammatory mediators which lead to abnormal tissue infiltration.
To date, there are only a few cases reporting ocular and orbital manifestations of mastocytosis.
Our prospective, interventional and single-center study consist in describing the ocular functional manifestations and ocular surface abnormalities of patients with systemic and cutaneous mastocytosis.
Read the detailed description
Patient with systemic or cutaneous mastocytosis will be included in the study. Data about organ involvement of mastocytosis will be collected. Participants will be screened with a medical and eye disease history. They will also have an eye exam.
Participants will provide a tears sample.
- Conditions
- Mast Cell Activation Disease, Mast Cell Activation Syndrome, Mast Cell Disease, Urticaria Pigmentosa
- Being tested
- Ophthalmological examination
- Medical subject headings
- Mast Cell Activation Disorders, Mast Cell Activation Syndrome, Urticaria Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmological examinationOther
Eye examination :
Ocular tonometry to determine intraocular pressure Refraction assessment Retina examination Slit lamp examination Visual acuity Schirmer's test Corneal topography Funduscopic examination Optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| Participants affected by cutaneous and systemic mastocytosis | Experimental | Participants affected by cutaneous and systemic mastocytosis with or without eye disabilities Receives: Other: Ophthalmological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects with mastocytosis presenting eye abnormalities
Number of patients with functional complaints or abnormalities of the surface, orbit, anterior and posterior segment of the eyeball.
Measured: up to 2 hours
Secondary outcomes (2)
Nature and Frequency of eye abnormalities
Details of functional complaints, abnormalities of various specialized examinations such as ocular tonometry to determine intraocular pressure, Refraction assessment, Retina examination, Slit lamp examination, Visual acuity, Schirmer's test, Corneal topography, Funduscopic examination, Optical coherence tomography
Measured: up to 2 hours
Risk factor of eye abnormalities
Significative association with a mastocytosis subtype or certain organ involvements or biological abnormalities
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start30 Jul 2021
- Primary completion3 Sep 2021
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mast Cell Activation DiseaseStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978740
- Sponsor's protocol ID
- MOOMA
- Status last verified
- Nov 2022
- First submitted
- 20 Jul 2021
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)
- ClinicalTrials.gov ID
- NCT04978740
- Acronym / sponsor ID
- MOOMA
- Conditions
- Mast Cell Activation Disease, Mast Cell Activation Syndrome, Mast Cell Disease, Urticaria Pigmentosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 27 Jul 2021 (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.
Mastocytosis is a rare condition characterized by an accumulation of mast cell cells in one or more organs such as the liver, bone marrow, spleen and intestines. Its prevalence in the general population is 1 in 10,000.
This pathology is due to the proliferation of a mast cell clone and the excessive release of inflammatory mediators which lead to abnormal tissue infiltration.
To date, there are only a few cases reporting ocular and orbital manifestations of mastocytosis.
Our prospective, interventional and single-center study consist in describing the ocular functional manifestations and ocular surface abnormalities of patients with systemic and cutaneous mastocytosis.
Detailed description
Patient with systemic or cutaneous mastocytosis will be included in the study. Data about organ involvement of mastocytosis will be collected. Participants will be screened with a medical and eye disease history. They will also have an eye exam.
Participants will provide a tears sample.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants affected by cutaneous and systemic mastocytosis | Experimental | Other: Ophthalmological examinationParticipants affected by cutaneous and systemic mastocytosis with or without eye disabilities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a diagnosis of mastocytosis
- Male or female, 18 years of age and over
- Ability to understand and provide written informed consent.
Key exclusion criteria (3 listed)
- Disorders that do not allow good visualization of the posterior pole (cataract, intravitreal hemorrhage)
- Patients with another ocular pathology that may bias the results (corneal dystrophy, dysthyroid orbitopathy, retinal pathologies)
- History of refractive surgery
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 |
|---|---|---|
| Ophthalmological examinationEye examination : Ocular tonometry to determine intraocular pressure Refraction assessment Retina examination Slit lamp examination Visual acuity Schirmer's test Corneal topography Funduscopic examination Optical coherence tomography | Other | Participants affected by cutaneous and systemic mastocytosis |
Primary outcome
Proportion of Subjects with mastocytosis presenting eye abnormalities
Time frame: up to 2 hours
Number of patients with functional complaints or abnormalities of the surface, orbit, anterior and posterior segment of the eyeball.
2 secondary outcomes
Nature and Frequency of eye abnormalities
Time frame: up to 2 hours
Risk factor of eye abnormalities
Time frame: up to 2 hours
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 1 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophthalmological examination in people with Mast Cell Activation Disease and Mast Cell Activation Syndrome, run by Poitiers University Hospital 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 3 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 1 Dec 2022. 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?
Proportion of Subjects with mastocytosis presenting eye abnormalities (time frame: up to 2 hours). 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 1 Dec 2022.