Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

NCT04978740 | Completed

• 1 other identifier: MOOMA
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 2 hours

Secondary Outcomes (2)

• Nature and Frequency of eye abnormalities

  up to 2 hours

• Risk factor of eye abnormalities

  up to 2 hours

Study Arms (1)

Participants affected by cutaneous and systemic mastocytosis

EXPERIMENTAL

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

Other: Ophthalmological examination

Interventions

Ophthalmological examination 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

Participants affected by cutaneous and systemic mastocytosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of mastocytosis
• Male or female, 18 years of age and over
• Ability to understand and provide written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Masson Regnault

Poitiers, Nouvelle-Aquitaine, 86000, France

Location

MeSH Terms

Conditions

Mast Cell Activation Disorders; Mast Cell Activation Syndrome; Urticaria Pigmentosa

Condition Hierarchy (Ancestors)

Immune System Diseases; Mastocytosis, Cutaneous; Mastocytosis; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Skin Neoplasms; Neoplasms by Site; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 27, 2021
• Study Start: July 30, 2021
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

FR (1)