Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

NCT ID: NCT04978740

Last Updated: 2022-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-30

Study Completion Date

2021-09-03

Brief Summary

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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

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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

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Mast Cell Activation Disease Mast Cell Activation Syndrome Mast Cell Disease Urticaria Pigmentosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Participants affected by cutaneous and systemic mastocytosis

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

Group Type EXPERIMENTAL

Ophthalmological examination

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Masson Regnault

Poitiers, Nouvelle-Aquitaine, France

Site Status

Countries

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France

Other Identifiers

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MOOMA

Identifier Type: -

Identifier Source: org_study_id

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