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

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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01695161

Acronym

MPSORA

Enrollment

Registered

2012-09-27

Start date

2012-09-30

Completion date

Unknown

Last updated

2013-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fabry Disease, Mucopolysaccharidosis

Keywords

Mucopolysaccharidosis, Fabry disease

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Germany

Outcome results