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NCT01695161 Clinical Trial

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

Fabry Disease Clinical Trial

— MPSORA  

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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01695161
Other study ID # MZ-MPS-2012-01
Secondary ID
Status Recruiting
Phase N/A
First received September 25, 2012
Last updated February 28, 2013
Start date September 2012

Study information
Verified date February 2013
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 75
Est. completion date
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Department of Ophthalmology, University Medical Center, Johannes Gutenberg- Mainz

Sponsors (1)
Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary agreement between ccIOP and GAT in MPS, Fabry and healthy controls Evaluation of agreement between ccIOP and GAT in MPS, Fabry and healthy controls Sep 2013 (anticipated) No
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