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Clinical Trials/NCT01695161
NCT01695161
Unknown
Not Applicable

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.

Johannes Gutenberg University Mainz1 site in 1 country75 target enrollmentSeptember 2012
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ConditionsMucopolysaccharidosisFabry Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mucopolysaccharidosis
Sponsor
Johannes Gutenberg University Mainz
Enrollment
75
Locations
1
Primary Endpoint
agreement between ccIOP and GAT in MPS, Fabry and healthy controls
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
September 2013
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Johannes Gutenberg University Mainz
Responsible Party
Principal Investigator
Principal Investigator

Susanne Pitz

MD

Johannes Gutenberg University Mainz

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (1)

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