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

February 28, 2013 updated by: Susanne Pitz, Johannes Gutenberg University Mainz

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.

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
healthy controls
mucopolysaccharidosis
Fabry disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Sep 2013 (anticipated)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

September 26, 2012

First Posted (Estimate)

September 27, 2012

Study Record Updates

Last Update Posted (Estimate)

March 1, 2013

Last Update Submitted That Met QC Criteria

February 28, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MZ-MPS-2012-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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