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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
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
July 20, 2021
Last Updated
November 30, 2022
Sponsor
Poitiers University Hospital
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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
No
Studies a U.S. FDA-regulated Device Product
No

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
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
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
No
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

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Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

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