Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

Not Applicable

Completed

• Conditions: Mast Cell Activation Syndrome; Mast Cell Disease; Mast Cell Activation Disease; Urticaria Pigmentosa
• Interventions: Other: Ophthalmological examination

• Registration Number: NCT04978740
• Lead Sponsor: Poitiers University Hospital

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.

Study Timeline

• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-27
• Study Start: 2021-07-30
• Primary Completion: 2021-09-03
• Study Completion: 2021-09-03
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants affected by cutaneous and systemic mastocytosis	Ophthalmological examination	Participants affected by cutaneous and systemic mastocytosis with or without eye disabilities

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Masson Regnault; 🇫🇷 Poitiers, Nouvelle Aquitaine, France