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

This study is currently recruiting participants.
Verified February 2013 by Johannes Gutenberg University Mainz
Sponsor:
Information provided by (Responsible Party):
Susanne Pitz, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01695161
First received: September 25, 2012
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Mucopolysaccharidosis
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:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
mucopolysaccharidosis
mucopolysaccharidosis
Fabry disease
Fabry disease
healthy controls
healthy controls

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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)

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695161

Locations
Germany
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
Investigators
Principal Investigator: Susanne Pitz, MD Department of Ophthalmology, University Medical Center, Johannes Gutenberg-
  More Information

No publications provided

Responsible Party: Susanne Pitz, MD, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01695161     History of Changes
Other Study ID Numbers: MZ-MPS-2012-01
Study First Received: September 25, 2012
Last Updated: February 28, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Johannes Gutenberg University Mainz:
Mucopolysaccharidosis
Fabry disease

Additional relevant MeSH terms:
Fabry Disease
Mucopolysaccharidoses
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, X-Linked
 Genetic Diseases, Inborn
Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders
Carbohydrate Metabolism, Inborn Errors
Mucinoses
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 16, 2013