Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
150 participants
OBSERVATIONAL
1996-01-31
2010-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
High-Resolution Ultrasound Imaging of the Retina and Choroid for Detection on Age Related Macular Degeneration
NCT00277784
Annular Array Ultrasound in Ophthalmology
NCT01415037
Adaptive Optics Imaging of Outer Retinal Diseases
NCT05355415
"Predicting Glaucoma Progression With Optical Coherence Tomography Structural and Angiographic Parameters".
NCT04646122
OCT Vibrography for Biomechanical Properties of Tissues
NCT05759780
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Subjects with glaucoma and age-matched normals
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.
high frequency ultrasound examination
high frequency ultrasound examination of the eye
3
subjects with tumors of the iris and ciliary body
high frequency ultrasound examination
high frequency ultrasound examination of the eye
4
subjects with age-related macular degeneration and age-matched normals
high frequency ultrasound examination
high frequency ultrasound examination of the eye
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
high frequency ultrasound examination
high frequency ultrasound examination of the eye
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Riverside Research Institute
OTHER
Weill Medical College of Cornell University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Weill Cornell Medical College
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
D. Jackson Coleman, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Cornell Medical College - New York Presbyterian Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Weill Cornell Medical College
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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. doi: 10.3928/1081-597X-20000701-04.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Weill Cornell Ophthalmology Research
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0703009082
Identifier Type: -
Identifier Source: secondary_id
EB00238
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.