Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation
1 other identifier
observational
54
1 country
1
Brief Summary
The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurements of drusen area and volume.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2011
Shorter than P25 for all trials
1 active site
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
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 24, 2013
CompletedFirst Posted
Study publicly available on registry
July 1, 2013
CompletedJuly 1, 2013
June 1, 2013
4 months
June 24, 2013
June 27, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 3 mm circle.
Single visit observation
Secondary Outcomes (1)
Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 3 mm circle.
Single visit observation
Other Outcomes (2)
Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 5 mm circle.
Single visit observation
Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 5 mm circle.
Single visit observation
Study Arms (1)
AMD with macular drusen
Patients diagnosed with dry AMD with macular drusen
Eligibility Criteria
Primary care clinic
You may qualify if:
- Males or females 50 years of age or older diagnosed to have dry AMD with macular drusen.
- Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization.
- Able and willing to make the required study visits.
- Able and willing to give consent and follow study instructions.
You may not qualify if:
- History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye.
- Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction.
- Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
- Concomitant use of hydrochloroquine or chloroquine.
- Unable to make the required study visits.
- Unable to give consent or follow study instructions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carl Zeiss Meditec, Inc.lead
- DataMed Devices Inc.collaborator
Study Sites (1)
Northern California Retina Vitreous Associates
Mountain View, California, 94040, United States
Related Publications (1)
Schmitz-Valckenberg S, Fleckenstein M, Scholl HP, Holz FG. Fundus autofluorescence and progression of age-related macular degeneration. Surv Ophthalmol. 2009 Jan-Feb;54(1):96-117. doi: 10.1016/j.survophthal.2008.10.004.
PMID: 19171212BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Wieland, MD
Northern California Retina Vitreous Associates Medical Group, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2013
First Posted
July 1, 2013
Study Start
February 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
July 1, 2013
Record last verified: 2013-06