Age Related Macular DegenerationNCT00277784
High-Resolution Ultrasound Imaging of the Retina and Choroid for Detection on Age Related Macular Degeneration
An observational study of Age Related Macular Degeneration, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The macula is the site of central vision within the retina. The retina is oxygenated by the underlying choroid. These tissues are less than 1 mm thick in total. While optical techniques can reveal much about the structure of the retina, ultrasound allows imaging of the choroid and deeper tissues. Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Ultrasound examination
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jun 2006
- 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 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ophthalmology practice
Who may be able to join
- Age related macular degeneration age matched control
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: High-Resolution Ultrasound Imaging of the Retina and Choroid
The macula is the site of central vision within the retina. The retina is oxygenated by the underlying choroid. These tissues are less than 1 mm thick in total. While optical techniques can reveal much about the structure of the retina, ultrasound allows imaging of the choroid and deeper tissues. This study will investigate use of high frequency (20 MHz) ultrasound for imaging of the retina and choroid in patients with age-related macular degeneration, a prime cause of blindness. The investigation will involve use of novel post-processing methodologies to achieve maximum resolution of the fine tissue structures involved in this disease.
Read the detailed description
Age-related macular degeneration (AMD), a condition affecting over 40% of individuals 70 years or age or more, causes progressive loss of central vision. Photocoagulation has long been used to slow the progress of AMD, but new vision-preserving methods are currently under investigation. Because destroyed photoreceptors are permanently lost, early management is essential for preservation of vision. The aim of this project will be to study AMD using a suite of new high-resolution ultrasound imaging techniques that have been developed. Specifically, high-resolution ultrasound will be used to generate images of the retina and choroid, including perfusion measurements using slow-flow methods developed by our research group. Ultrasound studies will be performed in conjunction with optical coherence tomography (OCT) imaging in a series of patients and age-matched control subjects with the aim of determining if choroidal thickness and/or perfusion might be used as an early indicator of AMD and thus aid in patient management.
We will study 20 subjects diagnosed with AMD. We will attempt to have an approximately equal number of subjects with wet and dry forms of AMD. A control group consisting of 20 non-AMD age-matched subjects will also be recruited. Ultrasound scan sequences will consist of B-mode images of the macula and surrounding tissues.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Ultrasound examination
- Keywords
- Age Related Macular Degeneration, Ultrasound, OCT, Eye
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examinationProcedure or surgery
Also called High Frequency Ultrasound
one ultrasound examination
| Study group | Role | What they receive |
|---|---|---|
| 1 | Individuals with age related macular degeneration Receives: Procedure: Ultrasound examination |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startJul 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Investigators
- Ronald H Silverman, PhD, Principal investigator, Weill Medical College of Cornell UniversityD. Jackson Coleman, MD, Study chair, Weill Cornell Medical College - New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277784
- Sponsor's protocol ID
- AIUM #1-2005
- Status last verified
- Mar 2008
- First submitted
- 12 Jan 2006
- Last updated
- 7 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Silverman RH. Ultrasound versus AC OCT. J Cataract Refract Surg. 2005 Aug;31(8):1475; author reply 1475-7. doi: 10.1016/j.jcrs.2005.08.011. No abstract available.
PubMed 16129261Coleman DJ, Silverman RH, Chabi A, Rondeau MJ, Shung KK, Cannata J, Lincoff H. High-resolution ultrasonic imaging of the posterior segment. Ophthalmology. 2004 Jul;111(7):1344-51. doi: 10.1016/j.ophtha.2003.10.029.
PubMed 15234135Coleman DJ, Silverman RH, Rondeau MJ, Lloyd HO, Khanifar AA, Chan RV. Age-related macular degeneration: choroidal ischaemia? Br J Ophthalmol. 2013 Aug;97(8):1020-3. doi: 10.1136/bjophthalmol-2013-303143. Epub 2013 Jun 5.
PubMed 23740965
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Resolution Ultrasound Imaging of the Retina and Choroid
- ClinicalTrials.gov ID
- NCT00277784
- Acronym / sponsor ID
- AIUM #1-2005
- Conditions
- Age Related Macular Degeneration
- Keywords
- Age Related Macular Degeneration, Ultrasound, OCT, Eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 16 Jan 2006 (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 macula is the site of central vision within the retina. The retina is oxygenated by the underlying choroid. These tissues are less than 1 mm thick in total. While optical techniques can reveal much about the structure of the retina, ultrasound allows imaging of the choroid and deeper tissues. This study will investigate use of high frequency (20 MHz) ultrasound for imaging of the retina and choroid in patients with age-related macular degeneration, a prime cause of blindness. The investigation will involve use of novel post-processing methodologies to achieve maximum resolution of the fine tissue structures involved in this disease.
Detailed description
Age-related macular degeneration (AMD), a condition affecting over 40% of individuals 70 years or age or more, causes progressive loss of central vision. Photocoagulation has long been used to slow the progress of AMD, but new vision-preserving methods are currently under investigation. Because destroyed photoreceptors are permanently lost, early management is essential for preservation of vision. The aim of this project will be to study AMD using a suite of new high-resolution ultrasound imaging techniques that have been developed. Specifically, high-resolution ultrasound will be used to generate images of the retina and choroid, including perfusion measurements using slow-flow methods developed by our research group. Ultrasound studies will be performed in conjunction with optical coherence tomography (OCT) imaging in a series of patients and age-matched control subjects with the aim of determining if choroidal thickness and/or perfusion might be used as an early indicator of AMD and thus aid in patient management.
We will study 20 subjects diagnosed with AMD. We will attempt to have an approximately equal number of subjects with wet and dry forms of AMD. A control group consisting of 20 non-AMD age-matched subjects will also be recruited. Ultrasound scan sequences will consist of B-mode images of the macula and surrounding tissues.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Ultrasound examinationIndividuals with age related macular degeneration |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ophthalmology practice
Key inclusion criteria (1 listed)
- Age related macular degeneration age matched control
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Ultrasound examinationAlso: High Frequency Ultrasoundone ultrasound examination | Procedure or surgery | 1 |
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 7 Mar 2008.
- Background: PubMed 16129261Silverman RH. Ultrasound versus AC OCT. J Cataract Refract Surg. 2005 Aug;31(8):1475; author reply 1475-7. doi: 10.1016/j.jcrs.2005.08.011. No abstract available.
- Background: PubMed 15234135Coleman DJ, Silverman RH, Chabi A, Rondeau MJ, Shung KK, Cannata J, Lincoff H. High-resolution ultrasonic imaging of the posterior segment. Ophthalmology. 2004 Jul;111(7):1344-51. doi: 10.1016/j.ophtha.2003.10.029.
- Derived from this study: PubMed 23740965Coleman DJ, Silverman RH, Rondeau MJ, Lloyd HO, Khanifar AA, Chan RV. Age-related macular degeneration: choroidal ischaemia? Br J Ophthalmol. 2013 Aug;97(8):1020-3. doi: 10.1136/bjophthalmol-2013-303143. Epub 2013 Jun 5.
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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.
Ronald H Silverman, PhD principal investigator
Weill Medical College of Cornell University
D. Jackson Coleman, MD study chair
Weill Cornell Medical College - New York Presbyterian Hospital
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 Age Related Macular Degeneration, run by Weill Medical College of Cornell University 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 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 7 Mar 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00277784, which also lists 3 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 7 Mar 2008.