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

NCT ID: NCT01695161

Last Updated: 2013-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Brief Summary

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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

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Conditions

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Mucopolysaccharidosis Fabry Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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mucopolysaccharidosis

mucopolysaccharidosis

No interventions assigned to this group

Fabry disease

Fabry disease

No interventions assigned to this group

healthy controls

healthy controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Susanne Pitz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susanne Pitz, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, University Medical Center, Johannes Gutenberg-

Locations

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Department of Ophthalmology, University Medical Center, Johannes Gutenberg-

Mainz, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Joanna Wasielica-Poslednik, MD

Role: primary

00496131173367

References

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Wasielica-Poslednik J, Politino G, Schmidtmann I, Lorenz K, Bell K, Pfeiffer N, Pitz S. Influence of Corneal Opacity on Intraocular Pressure Assessment in Patients with Lysosomal Storage Diseases. PLoS One. 2017 Jan 12;12(1):e0168698. doi: 10.1371/journal.pone.0168698. eCollection 2017.

Reference Type DERIVED
PMID: 28081172 (View on PubMed)

Other Identifiers

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MZ-MPS-2012-01

Identifier Type: -

Identifier Source: org_study_id

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