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Ultrasonic Evaluation of Ocular Tissues
This study is currently recruiting participants.
Verified by Weill Medical College of Cornell University, September 2008
Sponsors and Collaborators: Weill Medical College of Cornell University
Riverside Research Institute
Information provided by: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00279695
  Purpose

The objective of this research program is to improve diagnosis and treatment monitoring of ophthalmic disease by improving diagnostic ultrasound techniques. The program explores the use of novel signal and imaging processing techniques towards this end.


Condition Intervention
Glaucoma
Tumors
Age-Related Macular Degeneration
Procedure: high frequency ultrasound examination

Genetics Home Reference related topics: early-onset glaucoma X-linked juvenile retinoschisis
MedlinePlus related topics: Cancer Glaucoma Macular Degeneration Ultrasound
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Ultrasonic Evaluation of Ocular TIssues

Further study details as provided by Weill Medical College of Cornell University:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 150
Study Start Date: January 1996
Estimated Study Completion Date: June 2009
Groups/Cohorts Assigned Interventions
1
Subjects with glaucoma and age-matched normals
Procedure: high frequency ultrasound examination
high frequency ultrasound examination of the eye
2
normal volunteers, two age groups, one 18-25 years old, one 50 years and older.
Procedure: high frequency ultrasound examination
high frequency ultrasound examination of the eye
3
subjects with tumors of the iris and ciliary body
Procedure: high frequency ultrasound examination
high frequency ultrasound examination of the eye
4
subjects with age-related macular degeneration and age-matched normals
Procedure: high frequency ultrasound examination
high frequency ultrasound examination of the eye

Detailed Description:

This study involves the diagnosis of several eye diseases, as follows:

Glaucoma:

  1. Morphometry and spectral parameter assays: Clinical correlative studies in primary and secondary glaucoma subgroups: This is a volunteer study to obtain volumetric measurements of age-related changes in the ciliary body and individual ciliary muscle components. The study will provide baseline values for treatment monitoring studies of glaucoma therapeutics. There is minimal risk that the ultrasound procedure may reveal an occult ocular disease process, but the probability is very small. Patients will be informed and assisted in obtaining appropriate care if any abnormality is seen.
  2. Morphometry and spectral parameter assays: Ciliary body drug interactions in patients with initial diagnosis of open angle glaucoma: This study will attempt to document changes in anterior segment functional anatomy related to medical management of glaucoma. We hypothesize that several classes of anti-glaucoma drugs produce permanent modification of ciliary muscle vasculature that is related in turn to loss of drug efficacy over time. Data from COAG patients will be compared with age and sex matched normals. Participation in the study will not effect the ongoing glaucoma therapy of patients.

    Accommodation:

  3. Accommodative function in young emmetropes and transitional presbyopes: This is a volunteer study to develop a descriptive model of the human eye's focusing mechanism based on ultrasound morphometric measurements and spectral parameter assays. This study will measure dynamic changes in ciliary body spectral assays (size, CQ2) during calibrated accommodative tasks in volunteers with good amplitude of accommodation and those with accommodative loss do to aging and model 3-D conformal changes in anterior segment structures during accommodation. There is minimal risk that the ultrasound procedure may reveal an occult ocular disease process, but the probability is very small. Patients will be informed and assisted in obtaining appropriate care if any abnormality is seen.

    Ocular Tumors

  4. Tumors of the iris and ciliary body: This is an observational study of growth pattern changes in anterior melanoma for the purpose of identifying prognostic variables associated with rapid tumor growth. A percentage of small melanomas are observed for periods of up to several years before demonstrable growth will suggest more aggressive treatment. In the clinical ultrasound practice many patients with these tumors are seen at 3 to 6 month intervals to provide the ophthalmic oncologist with updated tumor volume data. We will examine changes in the ultrasound scattering structure of these tumors over time and their correlation with volume changes. The on-going research data are not released as part of the clinical ultrasound report.

    Age-related Macular Degeneration

  5. Posterior examinations: age-related macular degeneration: This study will examine the use of higher frequency (20-30 MHz) ultrasound in the early diagnosis of Age-related macular degeneration. Our hypothesis is that early changes in the choriocapillaries and choroid vascular density and conformation can be detected with high-frequency spectral assays. We will obtain ultrasound scans at frequencies of 20 MHz or more, as well as OCT and fundus photographs. Similar numbers of age-matched control subjects will be examined. Measurements of retinal and choroidal thickness profiles in the peri-macular region will be made. Spectral data will be used for morphologic vascular analysis (size and shape). Statistical comparison will be made using parametric and non-parametric methods between control and AMD groups.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Ophthalmology practice referrals

Criteria

Inclusion Criteria:

Have one of the following eye diseases Glaucoma Ocular Tumors Age-Related Macular Degeneration

Exclusion Criteria:

none

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279695

Contacts
Contact: Harriet O Lloyd, MS 212-746-6106 hlloyd@med.cornell.edu
Contact: Ronald H Silverman, PhD 212-746-6106 ros2012@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Riverside Research Institute
Investigators
Principal Investigator: D. Jackson Coleman, MD Weill Cornell Medical College - New York Presbyterian Hospital
  More Information

Additional Information:
Publications of Results:
Rondeau MJ, Barcsay G, Silverman RH, Reinstein DZ, Krishnamurthy R, Chabi A, Du T, Coleman DJ. Very high frequency ultrasound biometry of the anterior and posterior chamber diameter. J Refract Surg. 2004 Sep-Oct;20(5):454-64.
Coleman 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.
Coleman DJ, Silverman RH, Rondeau MJ, Boldt HC, Lloyd HO, Lizzi FL, Weingeist TA, Chen X, Vangveeravong S, Folberg R. Noninvasive in vivo detection of prognostic indicators for high-risk uveal melanoma: ultrasound parameter imaging. Ophthalmology. 2004 Mar;111(3):558-64.
Silverman RH, Folberg R, Rondeau MJ, Boldt HC, Lloyd HO, Chen X, Lizzi FL, Weingeist TA, Coleman DJ. Spectral parameter imaging for detection of prognostically significant histologic features in uveal melanoma. Ultrasound Med Biol. 2003 Jul;29(7):951-9.
Coleman DJ, Fish SK. Presbyopia, accommodation, and the mature catenary. Ophthalmology. 2001 Sep;108(9):1544-51.
Silverman RH, Lizzi FL, Ursea BG, Rondeau MJ, Eldeen NB, Kaliscz A, Lloyd HO, Coleman DJ. High-resolution ultrasonic imaging and characterization of the ciliary body. Invest Ophthalmol Vis Sci. 2001 Apr;42(5):885-94.
Reinstein DZ, Silverman RH, Raevsky T, Simoni GJ, Lloyd HO, Najafi DJ, Rondeau MJ, Coleman DJ. Arc-scanning very high-frequency digital ultrasound for 3D pachymetric mapping of the corneal epithelium and stroma in laser in situ keratomileusis. J Refract Surg. 2000 Jul-Aug;16(4):414-30. Erratum in: J Refract Surg 2001 Jan-Feb;7(1):4.
Reinstein DZ, Silverman RH, Sutton HF, Coleman DJ. Very high-frequency ultrasound corneal analysis identifies anatomic correlates of optical complications of lamellar refractive surgery: anatomic diagnosis in lamellar surgery. Ophthalmology. 1999 Mar;106(3):474-82.
Coleman DJ, Silverman RH, Daly SM, Rondeau MJ. Advances in ophthalmic ultrasound. Radiol Clin North Am. 1998 Nov;36(6):1073-82, x.
Patel S, Reinstein DZ, Silverman RH, Coleman DJ. The shape of Bowman's layer in the human cornea. J Refract Surg. 1998 Nov-Dec;14(6):636-40.
Kim DY, Reinstein DZ, Silverman RH, Najafi DJ, Belmont SC, Hatsis AP, Rozakis GW, Coleman DJ. Very high frequency ultrasound analysis of a new phakic posterior chamber intraocular lens in situ. Am J Ophthalmol. 1998 May;125(5):725-9.
Ursea R, Coleman DJ, Silverman RH, Lizzi FL, Daly SM, Harrison W. Correlation of high-frequency ultrasound backscatter with tumor microstructure in iris melanoma. Ophthalmology. 1998 May;105(5):906-12.
Cusumano A, Coleman DJ, Silverman RH, Reinstein DZ, Rondeau MJ, Ursea R, Daly SM, Lloyd HO. Three-dimensional ultrasound imaging. Clinical applications. Ophthalmology. 1998 Feb;105(2):300-6.
Silverman RH, Folberg R, Boldt HC, Lloyd HO, Rondeau MJ, Mehaffey MG, Lizzi FL, Coleman DJ. Correlation of ultrasound parameter imaging with microcirculatory patterns in uveal melanomas. Ultrasound Med Biol. 1997;23(4):573-81.
Silverman RH, Reinstein DZ, Raevsky T, Coleman DJ. Improved system for sonographic imaging and biometry of the cornea. J Ultrasound Med. 1997 Feb;16(2):117-24.
Ursea R, Heinemann MH, Silverman RH, Deangelis LM, Daly SW, Coleman DJ. Ophthalmic, ultrasonographic findings in primary central nervous system lymphoma with ocular involvement. Retina. 1997;17(2):118-23.
Danias J, Aslanides IM, Eichenbaum JW, Silverman RH, Reinstein DZ, Coleman DJ. Iridoschisis: high frequency ultrasound imaging. Evidence for a genetic defect? Br J Ophthalmol. 1996 Dec;80(12):1063-7.

Other Publications:
Responsible Party: Weill Cornell Medical College ( D. Jackson Coleman, MD )
Study ID Numbers: EB00238, 0295-775
Study First Received: January 17, 2006
Last Updated: September 17, 2008
ClinicalTrials.gov Identifier: NCT00279695  
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
Glaucoma
Accommodation
Ocular Tumors
Age-Related Macular Degeneration
Ultrasound
Eye

Study placed in the following topic categories:
Macular degeneration
Eye Neoplasms
Glaucoma
Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on February 12, 2009