Posterior Vitreous DetachmentNCT01415037
Annular Array Ultrasound in Ophthalmology
An observational study of Posterior Vitreous Detachment and Diabetic Retinopathy, run by Columbia University at 1 site in United States.
Trial summary
The objective of this research is to improve the care of ocular disease and disorders, in particular the changes in the eye associated with diabetes, by providing clinicians with dramatically improved ultrasonic images of the entire eye. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Posterior Vitreous Detachment, Diabetic Retinopathy
- What is being tested?
- annular array ultrasound exam
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2016
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: University-based Ophthalmology Practice
Who may be able to join
- over age 60
- people with diabetic retinopathy or posterior vitreous detachments
Who cannot join
- under age 60
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: High-frequency-ultrasound Annular Arrays for Ophthalmic Imaging
The objective of this research is to improve the care of ocular disease and disorders, in particular the changes in the eye associated with diabetes, by providing clinicians with dramatically improved ultrasonic images of the entire eye. The research combines advanced high-frequency, high-resolution ultrasonic annular arrays transducers with new processing techniques designed to overcome several limits that have been reached with conventional high frequency ultrasound systems. The investigators propose that diagnosis of eye diseases using annular arrays can be more effective than the conventional ultrasound images by at least 50%; i.e., that for every 2 posterior vitreous detachments detected conventionally, 3 will be detected with the annular arrays.
Read the detailed description
The goal of this study is to develop and evaluate advanced annular-array transducer technology for rapid, high-definition imaging. The study will assess high frequency ultrasound (HFU, 40 \& 20 MegaHertz) annular arrays in imaging posterior vitreous detachments (PVDs) associated with diabetic retinopathy, the leading cause of blindness in the US working-age population according to Prevent Blindness America. Current HFU instruments do not use linear arrays for such applications because of a variety of technical and cost reasons. Instead, current HFU instruments use mechanically scanned, single-element transducers, which provide fine-resolution images over a very limited depth of field (DOF). For ophthalmic applications, a shallow DOF causes most ocular anatomy to be imaged with poor definition compared to the in-focus region; therefore, because only a small portion of the eye is in focus at a given time, detection and assessment of ocular conditions such as PVD are prone to inaccuracies and false-negative determinations. Annular-array transducers offer a promising approach to significantly extend DOF and to increase the depth range over which fine-lateral resolution is provided. The investigators will validate system performance using animal experiments and human-subject examinations. First, in vivo animal experiments will be conducted to evaluate a 40-MegaHertz (MHz) annular array for anterior-segment imaging and a 20-MHz annular array for posterior segment and full-globe imaging. The investigators will test the hypothesis that 20-MHz annular arrays improve detection of PVD. Validation of this hypothesis will significantly improve our ability to assess disease status in diabetic retinopathy.
- Being tested
- annular array ultrasound exam
- Keywords
- Annular Array Ultrasound, Ultrasound Exam, Posterior Vitreous Detachment, PVD, Diabetic Retinopathy
- Medical subject headings
- Vitreous Detachment, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
annular array ultrasound examProcedure or surgery
For this research study you will be asked to sit in a chair. You will be given 2 drops of a numbing solution. The ultrasound camera will be enclosed in a sterile membrane and will be placed gently upon your eye. You may be asked to gaze at a light source while measurements are being made. The procedure will last about 10-15 minutes from start to finish.
| Study group | Role | What they receive |
|---|---|---|
| Annular Array Ultrasound | Subject with possible or with known posterior vitreous detachment. Subjects with diabetic retinopathy will receive annular array ultrasound exam. Receives: Procedure: annular array ultrasound exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in detection of posterior vitreous detachment: 20MHz annular array versus 10MHz single element
The investigators will examine eyes with both conventional 10MHz ultrasound and a 20MHz annular array with synthetic focusing. The investigators will evaluate and compare images acquired with both techniques and determine their relative efficacy in visualizing the presence or absence of posterior vitreous detachment.
Measured: Subjects will be examined with both the 20MHz annular array and 10MHz single element ultrasound during the same exam, approximately 30 minutes in duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Posterior Vitreous DetachmentStudies of the same condition, open and under way.
- More trials run by Columbia 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Riverside Research Institute, National Eye Institute (NEI)
- Responsible party
- Principal investigator, Ronald H. Silverman, Columbia University
- Investigators
- Ronald H Silverman, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415037
- Sponsor's protocol ID
- AAAF3057
- Other IDs
- R21EY024434
- Status last verified
- Jan 2019
- First submitted
- 25 Jul 2011
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Mamou J, Aristizabal O, Silverman RH, Ketterling JA, Turnbull DH. High-frequency chirp ultrasound imaging with an annular array for ophthalmologic and small-animal imaging. Ultrasound Med Biol. 2009 Jul;35(7):1198-208. doi: 10.1016/j.ultrasmedbio.2008.12.017. Epub 2009 Apr 25.
PubMed 19394754Mamou J, Ketterling JA, Silverman RH. Chirp-coded excitation imaging with a high-frequency ultrasound annular array. IEEE Trans Ultrason Ferroelectr Freq Control. 2008 Feb;55(2):508-13. doi: 10.1109/TUFFC.2008.670.
PubMed 18334358Silverman RH, Ketterling JA, Coleman DJ. High-frequency ultrasonic imaging of the anterior segment using an annular array transducer. Ophthalmology. 2007 Apr;114(4):816-22. doi: 10.1016/j.ophtha.2006.07.050. Epub 2006 Nov 30.
PubMed 17141314Filoux E, Sampathkumar A, Chitnis PV, Aristizabal O, Ketterling JA. High-frequency annular array with coaxial illumination for dual-modality ultrasonic and photoacoustic imaging. Rev Sci Instrum. 2013 May;84(5):053705. doi: 10.1063/1.4804636.
PubMed 23742556Lethiecq M, Lou-Moeller R, Ketterling J, Levassort F, Tran-Huu-Hue LP, Filoux E, Silverman RH, Wolny WW. Non-planar pad-printed thick-film focused high-frequency ultrasonic transducers for imaging and therapeutic applications. IEEE Trans Ultrason Ferroelectr Freq Control. 2012 Sep;59(9):1976-82. doi: 10.1109/TUFFC.2012.2416.
PubMed 23007770Mamou J, Wa CA, Yee KM, Silverman RH, Ketterling JA, Sadun AA, Sebag J. Ultrasound-based quantification of vitreous floaters correlates with contrast sensitivity and quality of life. Invest Ophthalmol Vis Sci. 2015 Jan 22;56(3):1611-7. doi: 10.1167/iovs.14-15414.
PubMed 25613948Silverman RH, Ketterling JA, Mamou J, Lloyd HO, Filoux E, Coleman DJ. Pulse-encoded ultrasound imaging of the vitreous with an annular array. Ophthalmic Surg Lasers Imaging. 2012 Jan-Feb;43(1):82-6. doi: 10.3928/15428877-20110901-03. Epub 2011 Sep 8.
PubMed 21902166
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-frequency-ultrasound Annular Arrays for Ophthalmic Imaging
- ClinicalTrials.gov ID
- NCT01415037
- Acronym / sponsor ID
- AAAF3057
- Keywords
- Annular Array Ultrasound, Ultrasound Exam, Posterior Vitreous Detachment, PVD, Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Riverside Research Institute, National Eye Institute (NEI)
- Study start
- Oct 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Aug 2011 (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 research is to improve the care of ocular disease and disorders, in particular the changes in the eye associated with diabetes, by providing clinicians with dramatically improved ultrasonic images of the entire eye. The research combines advanced high-frequency, high-resolution ultrasonic annular arrays transducers with new processing techniques designed to overcome several limits that have been reached with conventional high frequency ultrasound systems. The investigators propose that diagnosis of eye diseases using annular arrays can be more effective than the conventional ultrasound images by at least 50%; i.e., that for every 2 posterior vitreous detachments detected conventionally, 3 will be detected with the annular arrays.
Detailed description
The goal of this study is to develop and evaluate advanced annular-array transducer technology for rapid, high-definition imaging. The study will assess high frequency ultrasound (HFU, 40 \& 20 MegaHertz) annular arrays in imaging posterior vitreous detachments (PVDs) associated with diabetic retinopathy, the leading cause of blindness in the US working-age population according to Prevent Blindness America. Current HFU instruments do not use linear arrays for such applications because of a variety of technical and cost reasons. Instead, current HFU instruments use mechanically scanned, single-element transducers, which provide fine-resolution images over a very limited depth of field (DOF). For ophthalmic applications, a shallow DOF causes most ocular anatomy to be imaged with poor definition compared to the in-focus region; therefore, because only a small portion of the eye is in focus at a given time, detection and assessment of ocular conditions such as PVD are prone to inaccuracies and false-negative determinations. Annular-array transducers offer a promising approach to significantly extend DOF and to increase the depth range over which fine-lateral resolution is provided. The investigators will validate system performance using animal experiments and human-subject examinations. First, in vivo animal experiments will be conducted to evaluate a 40-MegaHertz (MHz) annular array for anterior-segment imaging and a 20-MHz annular array for posterior segment and full-globe imaging. The investigators will test the hypothesis that 20-MHz annular arrays improve detection of PVD. Validation of this hypothesis will significantly improve our ability to assess disease status in diabetic retinopathy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Annular Array Ultrasound | – | Procedure: annular array ultrasound examSubject with possible or with known posterior vitreous detachment. Subjects with diabetic retinopathy will receive annular array ultrasound exam. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- University-based Ophthalmology Practice
Key inclusion criteria (2 listed)
- over age 60
- people with diabetic retinopathy or posterior vitreous detachments
Key exclusion criteria (1 listed)
- under age 60
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 |
|---|---|---|
| annular array ultrasound examFor this research study you will be asked to sit in a chair. You will be given 2 drops of a numbing solution. The ultrasound camera will be enclosed in a sterile membrane and will be placed gently upon your eye. You may be asked to gaze at a light source while measurements are being made. The procedure will last about 10-15 minutes from start to finish. | Procedure or surgery | Annular Array Ultrasound |
Primary outcome
Change in detection of posterior vitreous detachment: 20MHz annular array versus 10MHz single element
Time frame: Subjects will be examined with both the 20MHz annular array and 10MHz single element ultrasound during the same exam, approximately 30 minutes in duration.
The investigators will examine eyes with both conventional 10MHz ultrasound and a 20MHz annular array with synthetic focusing. The investigators will evaluate and compare images acquired with both techniques and determine their relative efficacy in visualizing the presence or absence of posterior vitreous detachment.
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 30 Jan 2019.
- Background: PubMed 19394754Mamou J, Aristizabal O, Silverman RH, Ketterling JA, Turnbull DH. High-frequency chirp ultrasound imaging with an annular array for ophthalmologic and small-animal imaging. Ultrasound Med Biol. 2009 Jul;35(7):1198-208. doi: 10.1016/j.ultrasmedbio.2008.12.017. Epub 2009 Apr 25.
- Background: PubMed 18334358Mamou J, Ketterling JA, Silverman RH. Chirp-coded excitation imaging with a high-frequency ultrasound annular array. IEEE Trans Ultrason Ferroelectr Freq Control. 2008 Feb;55(2):508-13. doi: 10.1109/TUFFC.2008.670.
- Background: PubMed 17141314Silverman RH, Ketterling JA, Coleman DJ. High-frequency ultrasonic imaging of the anterior segment using an annular array transducer. Ophthalmology. 2007 Apr;114(4):816-22. doi: 10.1016/j.ophtha.2006.07.050. Epub 2006 Nov 30.
- Background: PubMed 23742556Filoux E, Sampathkumar A, Chitnis PV, Aristizabal O, Ketterling JA. High-frequency annular array with coaxial illumination for dual-modality ultrasonic and photoacoustic imaging. Rev Sci Instrum. 2013 May;84(5):053705. doi: 10.1063/1.4804636.
- Background: PubMed 23007770Lethiecq M, Lou-Moeller R, Ketterling J, Levassort F, Tran-Huu-Hue LP, Filoux E, Silverman RH, Wolny WW. Non-planar pad-printed thick-film focused high-frequency ultrasonic transducers for imaging and therapeutic applications. IEEE Trans Ultrason Ferroelectr Freq Control. 2012 Sep;59(9):1976-82. doi: 10.1109/TUFFC.2012.2416.
- Results publication: PubMed 25613948Mamou J, Wa CA, Yee KM, Silverman RH, Ketterling JA, Sadun AA, Sebag J. Ultrasound-based quantification of vitreous floaters correlates with contrast sensitivity and quality of life. Invest Ophthalmol Vis Sci. 2015 Jan 22;56(3):1611-7. doi: 10.1167/iovs.14-15414.
- Results publication: PubMed 21902166Silverman RH, Ketterling JA, Mamou J, Lloyd HO, Filoux E, Coleman DJ. Pulse-encoded ultrasound imaging of the vitreous with an annular array. Ophthalmic Surg Lasers Imaging. 2012 Jan-Feb;43(1):82-6. doi: 10.3928/15428877-20110901-03. Epub 2011 Sep 8.
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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
Columbia University
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 Posterior Vitreous Detachment and Diabetic Retinopathy, run by Columbia 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 2 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 30 Jan 2019. 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?
Change in detection of posterior vitreous detachment: 20MHz annular array versus 10MHz single element (time frame: Subjects will be examined with both the 20MHz annular array and 10MHz single element ultrasound during the same exam, approximately 30 minutes in duration.). 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 NCT01415037, which also lists 7 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 30 Jan 2019.