- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00731458
Prospective Comparison of Cirrus Versus Stratus Ocular Coherence Tomography for Different Retinal Pathology.
September 4, 2013 updated by: University of Chicago
Prospective Comparison of Cirrus and Stratus Optical Coherence Tomography for Quantifying Retinal Thickness
Ocular Coherence Tomography (OCT) is a non-invasive ophthalmologic test that uses reflected, unheated, non-concentrated visible light in order to scan and provide a 2-dimensional topographic analysis of the retina and optic nerve.
It has wide diagnostic utility especially in patients with clinically significant macular edema, glaucoma, and other retinal eye diseases.
At the University of Chicago, we have utilized the Stratus brand OCT (Carl Zeiss Inc) for the past 5 years.
Recently we have acquired a beta version of the company's new model, the Cirrus HD-OCT (Carl Zeiss Inc.) which features improved resolution, shorter scanning time and a more user-friendly interface.
The purpose of this study is to compare findings between the two models in patients with different common and uncommon eye diseases, including diabetic macular edema, glaucoma and age-related macular degeneration.
We hypothesis that the Cirrus OCT is able to accurately quantify eye pathology compared to Stratus OCT.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Any eye pathology that may cause macular edema.
Exclusion Criteria:
- Vitreous media opacities including dense cataracts, vitreous hemorrhage, and corneal opacities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Seenu Hariprasad, M.D., University Of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Forooghian F, Cukras C, Meyerle CB, Chew EY, Wong WT. Evaluation of time domain and spectral domain optical coherence tomography in the measurement of diabetic macular edema. Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4290-6. doi: 10.1167/iovs.08-2113. Epub 2008 May 30.
- Gupta V, Gupta P, Singh R, Dogra MR, Gupta A. Spectral-domain Cirrus high-definition optical coherence tomography is better than time-domain Stratus optical coherence tomography for evaluation of macular pathologic features in uveitis. Am J Ophthalmol. 2008 Jun;145(6):1018-1022. doi: 10.1016/j.ajo.2008.01.021. Epub 2008 Mar 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
August 6, 2008
First Submitted That Met QC Criteria
August 8, 2008
First Posted (Estimate)
August 11, 2008
Study Record Updates
Last Update Posted (Estimate)
September 5, 2013
Last Update Submitted That Met QC Criteria
September 4, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15606B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.