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OpenTrials
Completed

NCT Number: NCT04978740

Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

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.

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Key information

Conditions

Mast Cell Activation Disease Immune System Diseases Mast Cell Activation Disorders Mast Cell Activation Syndrome Mast Cell Disease Mastocytosis Mastocytosis, Cutaneous Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Pigmentation Disorders Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Urticaria Pigmentosa

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masson Regnault

Poitiers, New Aquitaine, 86000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Proportion of Subjects with mastocytosis presenting eye abnormalities

    Time frame: up to 2 hours

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

Secondary outcomes

  1. Nature and Frequency of eye abnormalities

    Time frame: 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

  2. Risk factor of eye abnormalities

    Time frame: up to 2 hours

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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2021
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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