NCT01928212

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

5 months

First QC Date

August 20, 2013

Last Update Submit

July 16, 2014

Conditions

Parkinson Disease

Keywords

retinal nerve fiber layer thicknessoptical coherence tomographyParkinson disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Study Arms (2)

healthy control

Sex- and agematched healthy subjects

Device: Optical coherence tomography

Parkinson group

Patients with Parkinson's disease

Device: Optical coherence tomography

Interventions

Optical coherence tomographyDEVICE
Parkinson grouphealthy control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

PD patients and healthy subjects were included and underwent OCT examinations

You may qualify if:

  • 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.

You may not qualify if:

  • authors did not make RNFL measurements;
  • study without healthy control group;
  • the outcome values can not be used for meta-analysis;
  • duplicated articles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (1)

  • 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.

    PMID: 24465663DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Yifan Feng, PhD

    Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Eye Hospital, Wenzhou Medical College, China

Study Record Dates

First Submitted

August 20, 2013

First Posted

August 23, 2013

Study Start

August 1, 2013

Primary Completion

January 1, 2014

Study Completion

May 1, 2014

Last Updated

July 18, 2014

Record last verified: 2014-07

Locations

CN(1)