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

• Conditions: Mucopolysaccharidosis; Fabry Disease

• Registration Number: NCT01695161
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-27
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-28
• Last Update Posted: 2013-03-01
• Primary Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Ophthalmology, University Medical Center, Johannes Gutenberg-; 🇩🇪 Mainz, Germany