Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

Sponsor

Poitiers University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04978740

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mast Cell Activation Disease Mast Cell Activation Syndrome Mast Cell Disease Urticaria Pigmentosa	Other: Ophthalmological examination	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

Actual Study Start Date :

Jul 30, 2021

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants affected by cutaneous and systemic mastocytosis Participants affected by cutaneous and systemic mastocytosis with or without eye disabilities	Other: Ophthalmological examination 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

Arm

Intervention/Treatment

Experimental: Participants affected by cutaneous and systemic mastocytosis

Participants affected by cutaneous and systemic mastocytosis with or without eye disabilities

Other: Ophthalmological examination

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 Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masson Regnault	Poitiers	Nouvelle Aquitaine	France	86000

Sponsors and Collaborators

Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT04978740

Other Study ID Numbers:

MOOMA

First Posted:

Jul 27, 2021

Last Update Posted:

Apr 13, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mastocytosis

Urticaria Pigmentosa

Urticaria

Study Results

No Results Posted as of Apr 13, 2022