Non-invasive Assessment of Intraocular Pressure in MPS by Use of the Ocular Response Analyzer.

NCT01695161 | Unknown

• 1 other identifier: MZ-MPS-2012-01
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to compare intraocular pressure (IOP) values assessed with Ocular Response Analyzer to the classical gold standard of IOP measurement, to Goldmann applanation tonometry by mucopolysacchyridosis-, Fabry-patients and healthy controls. We want to investigate biomechanical characteristics of the cornea and their influence on the IOP-measurements.

Conditions

Mucopolysaccharidosis; Fabry Disease

Keywords

Mucopolysaccharidosis; Fabry disease

Outcome Measures

Primary Outcomes (1)

• agreement between ccIOP and GAT in MPS, Fabry and healthy controls

  Evaluation of agreement between ccIOP and GAT in MPS, Fabry and healthy controls

  Sep 2013 (anticipated)

Study Arms (3)

mucopolysaccharidosis

mucopolysaccharidosis

Fabry disease

Fabry disease

healthy controls

healthy controls

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

25 eyes of MPS patients 25 eyes of Fabry patients 25 eyes of healthy age matched controls (a difference of ± 5 years in the mean between both groups is accepted)

You may qualify if:

• MPS I, II, IV, VI patients with at least grade 3 of corneal clouding (Couprie et al.)
• Fabry patients with cornea verticillata \> grade 1
• Age ≥ 12 years
• Patient is able to comply with the study procedure
• Patient has consented to be in the trial
• Ability to fixate a target

You may not qualify if:

• History of corneal transplantation or refractive surgery
• Corneal pathologies other than MPS-associated corneal opacity
• Corneal, conjunctival or intraocular inflammation

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Department of Ophthalmology, University Medical Center, Johannes Gutenberg-

Mainz, 55131, Germany

RECRUITING

Related Publications (1)

• Wasielica-Poslednik J, Politino G, Schmidtmann I, Lorenz K, Bell K, Pfeiffer N, Pitz S. Influence of Corneal Opacity on Intraocular Pressure Assessment in Patients with Lysosomal Storage Diseases. PLoS One. 2017 Jan 12;12(1):e0168698. doi: 10.1371/journal.pone.0168698. eCollection 2017.

  PMID: 28081172 DERIVED

MeSH Terms

Conditions

Mucopolysaccharidoses; Fabry Disease

Condition Hierarchy (Ancestors)

Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Sphingolipidoses; Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, X-Linked; Lipidoses; Lipid Metabolism, Inborn Errors; Lipid Metabolism Disorders

Study Officials

• Susanne Pitz, MD

  Department of Ophthalmology, University Medical Center, Johannes Gutenberg-

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: September 27, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Last Updated: March 1, 2013

Record last verified: 2013-02

Locations

DE (1)