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Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

Primary Purpose

Mast Cell Activation Disease, Mast Cell Activation Syndrome, Mast Cell Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Ophthalmological examination

About this trial

This is an interventional screening trial for Mast Cell Activation Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Masson Regnault

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants affected by cutaneous and systemic mastocytosis

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Risk factor of eye abnormalities

Significative association with a mastocytosis subtype or certain organ involvements or biological abnormalities

Full Information

NCT ID

NCT04978740

First Posted

July 20, 2021

Last Updated

November 30, 2022

Sponsor

Poitiers University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04978740

Brief Title

Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

Official Title

Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

July 30, 2021 (Actual)

Primary Completion Date

September 3, 2021 (Actual)

Study Completion Date

September 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Participants affected by cutaneous and systemic mastocytosis

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Ophthalmological examination

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of Subjects with mastocytosis presenting eye abnormalities

Description

Number of patients with functional complaints or abnormalities of the surface, orbit, anterior and posterior segment of the eyeball.

Time Frame

up to 2 hours

Secondary Outcome Measure Information:

Title

Nature and Frequency of eye abnormalities

Description

Time Frame

up to 2 hours

Title

Risk factor of eye abnormalities

Description

Significative association with a mastocytosis subtype or certain organ involvements or biological abnormalities

Time Frame

up to 2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Masson Regnault

City

Poitiers

State/Province

Nouvelle Aquitaine

ZIP/Postal Code

86000

Country

France

12. IPD Sharing Statement

Learn more about this trial

Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

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