High-frequency-ultrasound Annular Arrays for Ophthalmic Imaging

NCT00633854 | Completed DMC

• 1 other identifier: EB008606
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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. We 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.

Conditions

Posterior Vitreous Detachment

Keywords

annular array ultrasound; ophthalmic ultrasound; posterior vitreous detachment (PVD)

Outcome Measures

Primary Outcomes (1)

• detection of PVD in the posterior pole

  outcome measured at time of examination

Study Arms (1)

1

30 volunteer subjects who are age 60 and older

Procedure: Ultrasound examination

Interventions

Ultrasound examination PROCEDURE

Immersion Ultrasound Exam: In the immersion technique, the patient lies down on the examination table. A steridrape with a central aperture is used to form a water-tight seal around the eye. After installation of 2 drops of 0.5% proparacaine HCl, a wire lid speculum is used to hold the patient's lids open. Warm 0.9% sterile saline solution is then used to create a waterbath about 1/2 inch deep to provide acoustic coupling between the transducer and the eye. The transducer (either the 10- and 20-MHz sector scan probe or the annular array) is placed in the waterbath, but does not touch the eye.

1

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ophthalmology practice

You may qualify if:

• Subjects should be age 60 or older with possible posterior vitreous detachment in the back of the eye.

You may not qualify if:

• none

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Riverside Research Institute: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (2)

• Silverman RH, Ketterling JA, Mamou J, Coleman DJ. Improved high-resolution ultrasonic imaging of the eye. Arch Ophthalmol. 2008 Jan;126(1):94-7. doi: 10.1001/archopht.126.1.94.

  PMID: 18195224 BACKGROUND

• Silverman 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.

  PMID: 17141314 BACKGROUND

MeSH Terms

Conditions

Vitreous Detachment

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Ronald H Silverman, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: February 1, 2008
• Primary Completion: April 30, 2010
• Study Completion: April 30, 2010
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

US (1)