Parkinson DiseaseNCT01928212
Retinal Nerve Fiber Layer Thickness Changes in Parkinson Disease: A Meta-analysis
An observational study of Parkinson Disease, run by Yifan Feng at 1 site in China.
Trial summary
Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer (RNFL) and measure its thickness. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Optical coherence tomography
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to May 2014
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: PD patients and healthy subjects were included and underwent OCT examinations
Who may be able to join
- case-control studies;
- patients with PD were compared with healthy controls;
- all subjects underwent RNFL thickness measurement by OCT;
- studies should provide the data of peripapillary RNFL thickness;
- sample size ≥10 in each group.
Who cannot join
- authors did not make RNFL measurements;
- study without healthy control group;
- the outcome values can not be used for meta-analysis;
- duplicated articles.
Trial locations and contacts
1 site in 1 country.
About this study
Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's disease. Different studies have reported RNFL changes also in Parkinson's disease (PD),a common neurodegenerative disease characterized by motor dysfunctions, originally described by James Parkinson in 1817. PD is characterized by selective dopaminergic neuronal cells loss, which may correlate with RNFL thinning. Previous studies on this subject, however, reported contradicting results. Some investigations reported reductions of the RNFL thickness while others did not. In the present study, in order to determine whether RNFL thickness is reduced in PD patients, we performed a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series of PD patients and in the healthy control groups.
- Conditions
- Parkinson Disease
- Being tested
- Optical coherence tomography
- Keywords
- retinal nerve fiber layer thickness, optical coherence tomography, Parkinson disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomographyDevice
| Study group | Role | What they receive |
|---|---|---|
| healthy control | Sex- and agematched healthy subjects Receives: Device: Optical coherence tomography | |
| Parkinson group | Patients with Parkinson's disease Receives: Device: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Nerve Fiber Layer Thickness
Retinal nerve fiber layer thickness included average thickness (360° measurement), temporal quadrant thickness (316-45°), superior quadrant thickness (46-135°), nasal quadrant thickness (136-225°) and inferior quadrant thickness (226-315°)was measured by OCT.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completionMay 2014
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 Parkinson DiseaseStudies 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
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yifan Feng
- Sponsor type
- University, hospital or other
- Collaborators
- Wenzhou Medical University
- Responsible party
- Sponsor-investigator, Yifan Feng, Wenzhou Medical University
- Investigators
- Yifan Feng, PhD, Principal investigator, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928212
- Sponsor's protocol ID
- FYF20130820
- Status last verified
- Jul 2014
- First submitted
- 20 Aug 2013
- Last updated
- 18 Jul 2014
- Results posted
- No
Publications
Yu JG, Feng YF, Xiang Y, Huang JH, Savini G, Parisi V, Yang WJ, Fu XA. Retinal nerve fiber layer thickness changes in Parkinson disease: a meta-analysis. PLoS One. 2014 Jan 21;9(1):e85718. doi: 10.1371/journal.pone.0085718. eCollection 2014.
PubMed 24465663
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Nerve Fiber Layer Thickness Changes in Parkinson Disease: A Meta-analysis
- ClinicalTrials.gov ID
- NCT01928212
- Acronym / sponsor ID
- FYF20130820
- Conditions
- Parkinson Disease
- Keywords
- retinal nerve fiber layer thickness, optical coherence tomography, Parkinson disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Yifan FengUniversity, hospital or other
- Collaborators
- Wenzhou Medical University
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Aug 2013 (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.
Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's disease. Different studies have reported RNFL changes also in Parkinson's disease (PD),a common neurodegenerative disease characterized by motor dysfunctions, originally described by James Parkinson in 1817. PD is characterized by selective dopaminergic neuronal cells loss, which may correlate with RNFL thinning. Previous studies on this subject, however, reported contradicting results. Some investigations reported reductions of the RNFL thickness while others did not. In the present study, in order to determine whether RNFL thickness is reduced in PD patients, we performed a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series of PD patients and in the healthy control groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy control | – | Device: Optical coherence tomographySex- and agematched healthy subjects |
| Parkinson group | – | Device: Optical coherence tomographyPatients with Parkinson's disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- PD patients and healthy subjects were included and underwent OCT examinations
Key inclusion criteria (5 listed)
- case-control studies;
- patients with PD were compared with healthy controls;
- all subjects underwent RNFL thickness measurement by OCT;
- studies should provide the data of peripapillary RNFL thickness;
- sample size ≥10 in each group.
Key exclusion criteria (4 listed)
- authors did not make RNFL measurements;
- study without healthy control group;
- the outcome values can not be used for meta-analysis;
- duplicated articles.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherence tomography | Device | Parkinson group, healthy control |
Primary outcome
Retinal Nerve Fiber Layer Thickness
Time frame: Baseline
Retinal nerve fiber layer thickness included average thickness (360° measurement), temporal quadrant thickness (316-45°), superior quadrant thickness (46-135°), nasal quadrant thickness (136-225°) and inferior quadrant thickness (226-315°)was measured by OCT.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
- Derived from this study: PubMed 24465663Yu JG, Feng YF, Xiang Y, Huang JH, Savini G, Parisi V, Yang WJ, Fu XA. Retinal nerve fiber layer thickness changes in Parkinson disease: a meta-analysis. PLoS One. 2014 Jan 21;9(1):e85718. doi: 10.1371/journal.pone.0085718. eCollection 2014.
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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.
Yifan Feng, PhD principal investigator
Wenzhou Medical University
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 Parkinson Disease, run by Yifan Feng at 1 site in China.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 18 Jul 2014. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal Nerve Fiber Layer Thickness (time frame: Baseline). 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 NCT01928212, 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 18 Jul 2014.