Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

NCT04978740 — Not applicable, Completed, 21 participants, Poitiers University Hospital

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Registry	NCT04978740
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, screening
Enrollment	21 (Actual)
Sponsor	Poitiers University Hospital (Other)
Conditions	Mast Cell Activation Disease, Mast Cell Activation Syndrome, Mast Cell Disease, Urticaria Pigmentosa
Interventions	Ophthalmological examination (Other)
Dates	start 2021-07-30, primary completion 2021-09-03, completion 2021-09-03, first posted 2021-07-27, last updated 2022-12-01
Locations	1 site in France

-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.

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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Participants affected by cutaneous and systemic mastocytosis	Experimental	Other: Ophthalmological examination	Participants affected by cutaneous and systemic mastocytosis with or without eye disabilities

Ophthalmological examination (Other): 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

+Outcome measures

Primary outcomes

Proportion of Subjects with mastocytosis presenting eye abnormalities [up to 2 hours]: Number of patients with functional complaints or abnormalities of the surface, orbit, anterior and posterior segment of the eyeball.

Secondary outcomes

Nature and Frequency of eye abnormalities [up to 2 hours]: 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
Risk factor of eye abnormalities [up to 2 hours]: Significative association with a mastocytosis subtype or certain organ involvements or biological abnormalities

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Have a diagnosis of mastocytosis
* Male or female, 18 years of age and over
* Ability to understand and provide written informed consent.

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Masson Regnault	Poitiers, New Aquitaine	France