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

Sponsor
Johannes Gutenberg University Mainz (Other)
Overall Status
Unknown status
CT.gov ID
NCT01695161
Collaborator
(none)
75
Enrollment
1
Location

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Sep 1, 2012
    Anticipated Primary Completion Date :
    Sep 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    mucopolysaccharidosis

    mucopolysaccharidosis
    Fabry disease

    Fabry disease
    healthy controls

    healthy controls

    Outcome Measures

    Primary Outcome Measures

    1. agreement between ccIOP and GAT in MPS, Fabry and healthy controls [Sep 2013 (anticipated)]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology, University Medical Center, Johannes Gutenberg- Mainz Germany 55131

    Sponsors and Collaborators

    • Johannes Gutenberg University Mainz

    Investigators

    • Principal Investigator: Susanne Pitz, MD, Department of Ophthalmology, University Medical Center, Johannes Gutenberg-

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Susanne Pitz, MD, Johannes Gutenberg University Mainz
    ClinicalTrials.gov Identifier:
    NCT01695161
    Other Study ID Numbers:
    • MZ-MPS-2012-01
    First Posted:
    Sep 27, 2012
    Last Update Posted:
    Mar 1, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Susanne Pitz, MD, Johannes Gutenberg University Mainz
    Mucopolysaccharidosis
    Fabry disease
    Additional relevant MeSH terms:
    Fabry Disease
    Mucopolysaccharidoses

    Study Results

    No Results Posted as of Mar 1, 2013