Dry AMD With Macular DrusenNCT01890174
Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation
An observational study of Dry AMD With Macular Drusen, run by Carl Zeiss Meditec, Inc. at 1 site in United States.
Trial summary
The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurements of drusen area and volume. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dry AMD With Macular Drusen
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2011
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern California Retina Vitreous Associates
Mountain View, California, 94040
About this study
The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurements of drusen area and volume.
Read the detailed description
This is a prospective, single site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. The study will be divided into two phases. In Phase 1, the inter-device variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In each of these phases, the Macular Cube 200 x 200 scan and the Macular Cube 512 x 128 scan will be evaluated.
- Conditions
- Dry AMD With Macular Drusen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AMD with macular drusen | Patients diagnosed with dry AMD with macular drusen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 3 mm circle.
Measured: Single visit observation
Secondary outcomes (1)
Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 3 mm circle.
Measured: Single visit observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startFeb 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry AMD With Macular DrusenStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DataMed Devices Inc.
- Responsible party
- Sponsor
- Investigators
- Mark Wieland, MD, Principal investigator, Northern California Retina Vitreous Associates Medical Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890174
- Sponsor's protocol ID
- HD-OCT-DR-2010-2
- Status last verified
- Jun 2013
- First submitted
- 24 Jun 2013
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19171212
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation
- ClinicalTrials.gov ID
- NCT01890174
- Acronym / sponsor ID
- HD-OCT-DR-2010-2
- Conditions
- Dry AMD With Macular Drusen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec, Inc.Industry (pharma, biotech, devices)
- Collaborators
- DataMed Devices Inc.
- Study start
- Feb 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Jul 2013 (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.
The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurements of drusen area and volume.
Detailed description
This is a prospective, single site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. The study will be divided into two phases. In Phase 1, the inter-device variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In each of these phases, the Macular Cube 200 x 200 scan and the Macular Cube 512 x 128 scan will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMD with macular drusen | – | –Patients diagnosed with dry AMD with macular drusen |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 3 mm circle.
Time frame: Single visit observation
1 secondary outcome
Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 3 mm circle.
Time frame: Single visit observation
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 1 Jul 2013.
- Background: PubMed 19171212Schmitz-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.
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.
Mark Wieland, MD principal investigator
Northern California Retina Vitreous Associates Medical Group, Inc.
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 Dry AMD With Macular Drusen, run by Carl Zeiss Meditec, Inc. at 1 site in United States.
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 4 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 1 Jul 2013. 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 United States. 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?
Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 3 mm circle. (time frame: Single visit observation). 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 NCT01890174, which also lists 1 linked publication.
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 1 Jul 2013.