MucopolysaccharidosisMPSORANCT01695161
Non-invasive Assessment of Intraocular Pressure in MPS by Use of the Ocular Response Analyzer.
An observational study of Mucopolysaccharidosis and Fabry Disease, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mucopolysaccharidosis, Fabry Disease
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- History of corneal transplantation or refractive surgery
- Corneal pathologies other than MPS-associated corneal opacity
- Corneal, conjunctival or intraocular inflammation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, University Medical Center, Johannes Gutenberg-
Mainz, 55131
Joanna Wasielica-Poslednik, MD, 00496131173367, joanna.wasielica-poslednik@unimedizin-mainz.de
About this study
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.
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.
- Conditions
- Mucopolysaccharidosis, Fabry Disease
- Keywords
- Mucopolysaccharidosis, Fabry disease
- Medical subject headings
- Mucopolysaccharidoses, Fabry Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mucopolysaccharidosis | mucopolysaccharidosis | |
| Fabry disease | Fabry disease | |
| healthy controls | healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
agreement between ccIOP and GAT in MPS, Fabry and healthy controls
Evaluation of agreement between ccIOP and GAT in MPS, Fabry and healthy controls
Measured: Sep 2013 (anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MucopolysaccharidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Pitz, Johannes Gutenberg University Mainz
- Investigators
- Susanne Pitz, MD, Principal investigator, Department of Ophthalmology, University Medical Center, Johannes Gutenberg-
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695161
- Sponsor's protocol ID
- MZ-MPS-2012-01
- Acronym
- MPSORA
- Status last verified
- Feb 2013
- First submitted
- 25 Sep 2012
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28081172
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01695161
- Acronym / sponsor ID
- MPSORA / MZ-MPS-2012-01
- Conditions
- Mucopolysaccharidosis, Fabry Disease
- Keywords
- Mucopolysaccharidosis, Fabry disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mucopolysaccharidosis | – | –mucopolysaccharidosis |
| Fabry disease | – | –Fabry disease |
| healthy controls | – | –healthy controls |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- History of corneal transplantation or refractive surgery
- Corneal pathologies other than MPS-associated corneal opacity
- Corneal, conjunctival or intraocular inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
- Derived from this study: PubMed 28081172Wasielica-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Ophthalmology, University Medical Center, Johannes Gutenberg-
Mainz, Germany
Susanne Pitz, MD principal investigator
Department of Ophthalmology, University Medical Center, Johannes Gutenberg-
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucopolysaccharidosis and Fabry Disease, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
agreement between ccIOP and GAT in MPS, Fabry and healthy controls (time frame: Sep 2013 (anticipated)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01695161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2013.