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

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ClinicalTrials.gov Identifier: NCT01695161
Recruitment Status : Unknown
Verified February 2013 by Susanne Pitz, Johannes Gutenberg University Mainz.
Recruitment status was:  Recruiting
First Posted : September 27, 2012
Last Update Posted : March 1, 2013
Information provided by (Responsible Party):
Susanne Pitz, Johannes Gutenberg University Mainz

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.

Condition or disease
Mucopolysaccharidosis Fabry Disease

Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Corneal-Compensated Intraocular Pressure, Corneal Hysteresis and Corneal Resistance Factor Measurements Performed With the Ocular Response Analyzer and Their Correlation to Conventional Goldmann Applanation Tonometry.
Study Start Date : September 2012
Estimated Primary Completion Date : September 2013

Fabry disease
Fabry disease
healthy controls
healthy controls

Primary Outcome Measures :
  1. agreement between ccIOP and GAT in MPS, Fabry and healthy controls [ Time Frame: Sep 2013 (anticipated) ]
    Evaluation of agreement between ccIOP and GAT in MPS, Fabry and healthy controls

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695161

Department of Ophthalmology, University Medical Center, Johannes Gutenberg- Recruiting
Mainz, Germany, 55131
Contact: Joanna Wasielica-Poslednik, MD    00496131173367    joanna.wasielica-poslednik@unimedizin-mainz.de   
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Principal Investigator: Susanne Pitz, MD Department of Ophthalmology, University Medical Center, Johannes Gutenberg-

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susanne Pitz, MD, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01695161     History of Changes
Other Study ID Numbers: MZ-MPS-2012-01
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: March 1, 2013
Last Verified: February 2013

Keywords provided by Susanne Pitz, Johannes Gutenberg University Mainz:
Fabry disease

Additional relevant MeSH terms:
Fabry Disease
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
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders
Carbohydrate Metabolism, Inborn Errors
Connective Tissue Diseases