HealthyNCT00643422
Reproducibility of Cirrus Optical Coherence Tomography Measurements
An observational study of Healthy, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial summary
In this study the reproducibility of optical coherence tomography measurements should be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cirrus™ HD-OCT, Carl Zeiss Meditec AG
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- Start not givento not given
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: attendants of health care center
Who may be able to join
- 18 years of age or older
- best corrected visual acuity of at least 20/25
- clear optical media
Who cannot join
- any kind of retinal pathology
- any kind of opacity of optical media
- any kind of intraocular surgery
- spherical refraction of more than 5 diopters
- cylindrical refraction of more than 3 diopters
- amblyopia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reproducibility of Retinal Thickness and Volume Measurements Determined With the Cirrus Spectral Domain OCT
In this study the reproducibility of optical coherence tomography measurements should be evaluated.
- Conditions
- Healthy
- Being tested
- Cirrus™ HD-OCT, Carl Zeiss Meditec AG
- Keywords
- normal eyes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cirrus™ HD-OCT, Carl Zeiss Meditec AGDevice
the retinal thickness and volume is determined on two different days with the Cirrus™ HD-OCT.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Not described Receives: Device: Cirrus™ HD-OCT, Carl Zeiss Meditec AG |
What is being measured
The primary outcome is the main question the study is designed to answer.
retinal thickness
Measured: two
Secondary outcomes (1)
retinal volume
Measured: two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643422
- Sponsor's protocol ID
- Cirrus_OCT_0308
- Status last verified
- Jul 2008
- First submitted
- 22 Mar 2008
- Last updated
- 22 Jul 2008
- Results posted
- No
Publications
Wang XY, Huynh SC, Burlutsky G, Ip J, Stapleton F, Mitchell P. Reproducibility of and effect of magnification on optical coherence tomography measurements in children. Am J Ophthalmol. 2007 Mar;143(3):484-8. doi: 10.1016/j.ajo.2006.11.042. Epub 2006 Dec 22.
PubMed 17317392Paunescu LA, Schuman JS, Price LL, Stark PC, Beaton S, Ishikawa H, Wollstein G, Fujimoto JG. Reproducibility of nerve fiber thickness, macular thickness, and optic nerve head measurements using StratusOCT. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1716-24. doi: 10.1167/iovs.03-0514.
PubMed 15161831Polito A, Del Borrello M, Isola M, Zemella N, Bandello F. Repeatability and reproducibility of fast macular thickness mapping with stratus optical coherence tomography. Arch Ophthalmol. 2005 Oct;123(10):1330-7. doi: 10.1001/archopht.123.10.1330.
PubMed 16219723Danis RP, Fisher MR, Lambert E, Goulding A, Wu D, Lee LY. Results and repeatability of retinal thickness measurements from certification submissions. Arch Ophthalmol. 2008 Jan;126(1):45-50. doi: 10.1001/archopht.126.1.45.
PubMed 18195217Sadda SR, Tan O, Walsh AC, Schuman JS, Varma R, Huang D. Automated detection of clinically significant macular edema by grid scanning optical coherence tomography. Ophthalmology. 2006 Jul;113(7):1187.e1-12. doi: 10.1016/j.ophtha.2005.12.020. Epub 2006 May 2.
PubMed 16647123Budenz DL, Fredette MJ, Feuer WJ, Anderson DR. Reproducibility of peripapillary retinal nerve fiber thickness measurements with stratus OCT in glaucomatous eyes. Ophthalmology. 2008 Apr;115(4):661-666.e4. doi: 10.1016/j.ophtha.2007.05.035. Epub 2007 Aug 13.
PubMed 17706287Hsu SY, Tsai RK. Analysis of retinal nerve fiber layer and macular thickness measurements in healthy Taiwanese individuals using optical coherence tomography (Stratus OCT). J Glaucoma. 2008 Jan-Feb;17(1):30-5. doi: 10.1097/IJG.0b013e31811243b4.
PubMed 18303381Diabetic Retinopathy Clinical Research Network; Krzystolik MG, Strauber SF, Aiello LP, Beck RW, Berger BB, Bressler NM, Browning DJ, Chambers RB, Danis RP, Davis MD, Glassman AR, Gonzalez VH, Greenberg PB, Gross JG, Kim JE, Kollman C. Reproducibility of macular thickness and volume using Zeiss optical coherence tomography in patients with diabetic macular edema. Ophthalmology. 2007 Aug;114(8):1520-5. doi: 10.1016/j.ophtha.2006.10.055. Epub 2007 Mar 13.
PubMed 17353052Hagen S, Krebs I, Haas P, Glittenberg C, Falkner-Radler CI, Graf A, Ansari-Shahrezaei S, Binder S. Reproducibility and comparison of retinal thickness and volume measurements in normal eyes determined with two different Cirrus OCT scanning protocols. Retina. 2011 Jan;31(1):41-7. doi: 10.1097/IAE.0b013e3181dde71e.
PubMed 20838360
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Retinal Thickness and Volume Measurements Determined With the Cirrus Spectral Domain OCT
- ClinicalTrials.gov ID
- NCT00643422
- Acronym / sponsor ID
- Cirrus_OCT_0308
- Conditions
- Healthy
- Keywords
- normal eyes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- First posted
- 26 Mar 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.
In this study the reproducibility of optical coherence tomography measurements should be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Device: Cirrus™ HD-OCT, Carl Zeiss Meditec AG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- attendants of health care center
Key inclusion criteria (3 listed)
- 18 years of age or older
- best corrected visual acuity of at least 20/25
- clear optical media
Key exclusion criteria (6 listed)
- any kind of retinal pathology
- any kind of opacity of optical media
- any kind of intraocular surgery
- spherical refraction of more than 5 diopters
- cylindrical refraction of more than 3 diopters
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 |
|---|---|---|
| Cirrus™ HD-OCT, Carl Zeiss Meditec AGthe retinal thickness and volume is determined on two different days with the Cirrus™ HD-OCT. | Device | Observation |
Primary outcome
retinal thickness
Time frame: two
1 secondary outcome
retinal volume
Time frame: two
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 22 Jul 2008.
- Background: PubMed 17317392Wang XY, Huynh SC, Burlutsky G, Ip J, Stapleton F, Mitchell P. Reproducibility of and effect of magnification on optical coherence tomography measurements in children. Am J Ophthalmol. 2007 Mar;143(3):484-8. doi: 10.1016/j.ajo.2006.11.042. Epub 2006 Dec 22.
- Background: PubMed 15161831Paunescu LA, Schuman JS, Price LL, Stark PC, Beaton S, Ishikawa H, Wollstein G, Fujimoto JG. Reproducibility of nerve fiber thickness, macular thickness, and optic nerve head measurements using StratusOCT. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1716-24. doi: 10.1167/iovs.03-0514.
- Background: PubMed 16219723Polito A, Del Borrello M, Isola M, Zemella N, Bandello F. Repeatability and reproducibility of fast macular thickness mapping with stratus optical coherence tomography. Arch Ophthalmol. 2005 Oct;123(10):1330-7. doi: 10.1001/archopht.123.10.1330.
- Background: PubMed 18195217Danis RP, Fisher MR, Lambert E, Goulding A, Wu D, Lee LY. Results and repeatability of retinal thickness measurements from certification submissions. Arch Ophthalmol. 2008 Jan;126(1):45-50. doi: 10.1001/archopht.126.1.45.
- Background: PubMed 16647123Sadda SR, Tan O, Walsh AC, Schuman JS, Varma R, Huang D. Automated detection of clinically significant macular edema by grid scanning optical coherence tomography. Ophthalmology. 2006 Jul;113(7):1187.e1-12. doi: 10.1016/j.ophtha.2005.12.020. Epub 2006 May 2.
- Background: PubMed 17706287Budenz DL, Fredette MJ, Feuer WJ, Anderson DR. Reproducibility of peripapillary retinal nerve fiber thickness measurements with stratus OCT in glaucomatous eyes. Ophthalmology. 2008 Apr;115(4):661-666.e4. doi: 10.1016/j.ophtha.2007.05.035. Epub 2007 Aug 13.
- Background: PubMed 18303381Hsu SY, Tsai RK. Analysis of retinal nerve fiber layer and macular thickness measurements in healthy Taiwanese individuals using optical coherence tomography (Stratus OCT). J Glaucoma. 2008 Jan-Feb;17(1):30-5. doi: 10.1097/IJG.0b013e31811243b4.
- Background: PubMed 17353052Diabetic Retinopathy Clinical Research Network; Krzystolik MG, Strauber SF, Aiello LP, Beck RW, Berger BB, Bressler NM, Browning DJ, Chambers RB, Danis RP, Davis MD, Glassman AR, Gonzalez VH, Greenberg PB, Gross JG, Kim JE, Kollman C. Reproducibility of macular thickness and volume using Zeiss optical coherence tomography in patients with diabetic macular edema. Ophthalmology. 2007 Aug;114(8):1520-5. doi: 10.1016/j.ophtha.2006.10.055. Epub 2007 Mar 13.
- Derived from this study: PubMed 20838360Hagen S, Krebs I, Haas P, Glittenberg C, Falkner-Radler CI, Graf A, Ansari-Shahrezaei S, Binder S. Reproducibility and comparison of retinal thickness and volume measurements in normal eyes determined with two different Cirrus OCT scanning protocols. Retina. 2011 Jan;31(1):41-7. doi: 10.1097/IAE.0b013e3181dde71e.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
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 3 inclusion and 6 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 22 Jul 2008. 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 Austria. 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 thickness (time frame: two). 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 NCT00643422, which also lists 9 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 22 Jul 2008.