Retinal PathologyNCT00731458
Prospective Comparison of Cirrus Versus Stratus Ocular Coherence Tomography for Different Retinal Pathology.
A study testing Optical coherance tomography ( Cirrus; Stratus) in people with Retinal Pathology, run by University of Chicago.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Pathology
- What is being tested?
- Optical coherance tomography ( Cirrus; Stratus)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Nov 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any eye pathology that may cause macular edema.
Who cannot join
- Vitreous media opacities including dense cataracts, vitreous hemorrhage, and corneal opacities
About this study
Official title: 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.
- Conditions
- Retinal Pathology
- Being tested
- Optical coherance tomography ( Cirrus; Stratus)
- Keywords
- OCT;, Cirrus;, Stratus;, macular thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherance tomography ( Cirrus; Stratus)Device
Also called OCT; Cirrus; Stratus
Non-contact retinal thickness analyzer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startMay 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinal PathologyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Research to Prevent Blindness
- Responsible party
- Sponsor
- Investigators
- Seenu Hariprasad, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731458
- Sponsor's protocol ID
- 15606B
- Status last verified
- Sep 2013
- First submitted
- 6 Aug 2008
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18515567Gupta 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.
PubMed 18343349
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Cirrus and Stratus Optical Coherence Tomography for Quantifying Retinal Thickness
- ClinicalTrials.gov ID
- NCT00731458
- Acronym / sponsor ID
- 15606B
- Conditions
- Retinal Pathology
- Keywords
- OCT;, Cirrus;, Stratus;, macular thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Research to Prevent Blindness
- Study start
- May 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 11 Aug 2008 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any eye pathology that may cause macular edema.
Key exclusion criteria (1 listed)
- Vitreous media opacities including dense cataracts, vitreous hemorrhage, and corneal opacities
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 coherance tomography ( Cirrus; Stratus)Also: OCT; Cirrus; StratusNon-contact retinal thickness analyzer | Device | – |
Primary outcome
Not reported in the source record.
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 5 Sep 2013.
- Background: PubMed 18515567Forooghian 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.
- Background: PubMed 18343349Gupta 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.
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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.
Seenu Hariprasad, M.D. principal investigator
University of Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Optical coherance tomography ( Cirrus; Stratus) in people with Retinal Pathology, run by University of Chicago.
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 1 inclusion and 1 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 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00731458, which also lists 2 linked publications.
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 5 Sep 2013.