Ultrasonic Evaluation of Ocular Tissues

NCT ID: NCT00279695

Last Updated: 2010-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-01-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Glaucoma Tumors Age-Related Macular Degeneration

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Subjects with glaucoma and age-matched normals

high frequency ultrasound examination

Intervention Type PROCEDURE

high frequency ultrasound examination of the eye

2

normal volunteers, two age groups, one 18-25 years old, one 50 years and older.

high frequency ultrasound examination

Intervention Type PROCEDURE

high frequency ultrasound examination of the eye

3

subjects with tumors of the iris and ciliary body

high frequency ultrasound examination

Intervention Type PROCEDURE

high frequency ultrasound examination of the eye

4

subjects with age-related macular degeneration and age-matched normals

high frequency ultrasound examination

Intervention Type PROCEDURE

high frequency ultrasound examination of the eye

Interventions

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high frequency ultrasound examination

high frequency ultrasound examination of the eye

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

none
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Riverside Research Institute

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Weill Cornell Medical College

Principal Investigators

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D. Jackson Coleman, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medical College - New York Presbyterian Hospital

Locations

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Weill Cornell Medical College

New York, New York, United States

Site Status

Countries

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United States

References

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Silverman RH, Ursea R, Kruse D, Ferrara KW, Rondeau MJ, Coleman DJ. Ultrasound measurement of the effect of temperature on microperfusion in the eye. Ultrasound Med Biol. 2002 Nov-Dec;28(11-12):1413-9. doi: 10.1016/s0301-5629(02)00694-4.

Reference Type BACKGROUND
PMID: 12498936 (View on PubMed)

Silverman RH, Kruse DE, Coleman DJ, Ferrara KW. High-resolution ultrasonic imaging of blood flow in the anterior segment of the eye. Invest Ophthalmol Vis Sci. 1999 Jun;40(7):1373-81.

Reference Type BACKGROUND
PMID: 10359319 (View on PubMed)

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. doi: 10.3928/1081-597X-20040901-08.

Reference Type RESULT
PMID: 15523957 (View on PubMed)

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. doi: 10.1016/j.ophtha.2003.10.029.

Reference Type RESULT
PMID: 15234135 (View on PubMed)

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. doi: 10.1016/j.ophtha.2003.06.021.

Reference Type RESULT
PMID: 15019336 (View on PubMed)

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. doi: 10.1016/s0301-5629(03)00907-4.

Reference Type RESULT
PMID: 12878240 (View on PubMed)

Coleman DJ, Fish SK. Presbyopia, accommodation, and the mature catenary. Ophthalmology. 2001 Sep;108(9):1544-51. doi: 10.1016/s0161-6420(01)00691-1.

Reference Type RESULT
PMID: 11535447 (View on PubMed)

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.

Reference Type RESULT
PMID: 11274063 (View on PubMed)

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. doi: 10.3928/1081-597X-20000701-04.

Reference Type RESULT
PMID: 10939721 (View on PubMed)

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. doi: 10.1016/S0161-6420(99)90105-7.

Reference Type RESULT
PMID: 10080202 (View on PubMed)

Coleman DJ, Silverman RH, Daly SM, Rondeau MJ. Advances in ophthalmic ultrasound. Radiol Clin North Am. 1998 Nov;36(6):1073-82, x. doi: 10.1016/s0033-8389(05)70232-3.

Reference Type RESULT
PMID: 9884689 (View on PubMed)

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. doi: 10.3928/1081-597X-19981101-11.

Reference Type RESULT
PMID: 9866103 (View on PubMed)

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. doi: 10.1016/s0002-9394(98)00025-7.

Reference Type RESULT
PMID: 9625568 (View on PubMed)

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. doi: 10.1016/S0161-6420(98)95036-9.

Reference Type RESULT
PMID: 9593396 (View on PubMed)

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. doi: 10.1016/s0161-6420(98)93211-0.

Reference Type RESULT
PMID: 9479291 (View on PubMed)

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. doi: 10.1016/s0301-5629(97)00037-9.

Reference Type RESULT
PMID: 9232766 (View on PubMed)

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. doi: 10.7863/jum.1997.16.2.117.

Reference Type RESULT
PMID: 9166804 (View on PubMed)

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. doi: 10.1097/00006982-199703000-00006.

Reference Type RESULT
PMID: 9143039 (View on PubMed)

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. doi: 10.1136/bjo.80.12.1063.

Reference Type RESULT
PMID: 9059271 (View on PubMed)

Related Links

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http://weillcornelleye.org/research/

Weill Cornell Ophthalmology Research

Other Identifiers

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0703009082

Identifier Type: -

Identifier Source: secondary_id

EB00238

Identifier Type: -

Identifier Source: org_study_id

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