Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

Mast Cell Activation Syndrome Clinical Trial

Official title:

Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04978740
• Other study ID #: MOOMA
• Status: Completed
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: September 3, 2021

Study information

• Verified date: November 2022
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 3, 2021
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mast Cell Activation Syndrome
• Mastocytosis
• Urticaria
• Urticaria Pigmentosa

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Masson Regnault	Poitiers	Nouvelle Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	up to 2 hours
Secondary	Risk factor of eye abnormalities	Significative association with a mastocytosis subtype or certain organ involvements or biological abnormalities	up to 2 hours