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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Johannes Gutenberg University Mainz.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Susanne Pitz, Johannes Gutenberg University Mainz Identifier:
First received: September 25, 2012
Last updated: February 28, 2013
Last verified: February 2013
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.

Fabry Disease

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 75
Study Start Date: September 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Fabry disease
Fabry disease
healthy controls
healthy controls


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01695161

Department of Ophthalmology, University Medical Center, Johannes Gutenberg- Recruiting
Mainz, Germany, 55131
Contact: Joanna Wasielica-Poslednik, MD    00496131173367   
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Principal Investigator: Susanne Pitz, MD Department of Ophthalmology, University Medical Center, Johannes Gutenberg-
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Susanne Pitz, MD, Johannes Gutenberg University Mainz Identifier: NCT01695161     History of Changes
Other Study ID Numbers: MZ-MPS-2012-01
Study First Received: September 25, 2012
Last Updated: February 28, 2013

Keywords provided by Johannes Gutenberg University Mainz:
Fabry disease

Additional relevant MeSH terms:
Fabry Disease
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lysosomal Storage Diseases
Connective Tissue Diseases
Metabolic Diseases
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
Lipid Metabolism, Inborn Errors
Lipid Metabolism Disorders processed this record on May 24, 2017