Annular Array Ultrasound in Ophthalmology
Recruitment status was Active, not recruiting
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.
Posterior Vitreous Detachment
Procedure: annular array ultrasound exam
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||High-frequency-ultrasound Annular Arrays for Ophthalmic Imaging|
- Detection of posterior vitreous detachment: 20MHz annular array versus 10MHz single element [ Time Frame: Subjects will be examined with both the 20MHz annunlar array and 10MHz single element ultrasound during the same exam, approximately 30 minutes in duration. ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Annular Array Ultrasound
Subject with possible or with known posterior vitreous detachment. Subjects with diabetic retinopathy.
Procedure: annular array ultrasound exam
For this research study you will be asked to lie down on the exam table. A plastic drape with a central hole will be used to form a watertight seal around your eye. After giving you 2 drops of a numbing solution, warm 0.9% sterile saline solution (like natural tears) will be poured into the drape and it will cover your eye. The ultrasound camera will then be placed in the waterbath, but does not touch your eye. You will 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.
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 MHz) 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-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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415037
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Ronald H Silverman, PhD||Columbia University|