Treatment Trials

78 Clinical Trials for Various Conditions

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COMPLETED
Does the VTS1000 Infra Red Vein Imager Allow Better Identification of Veins Than Normal Eyesight?
Description

VueTek has developed a head mounted device that will improve the viewing of superficial, subcutaneous vasculature, differentiating it with higher contrast from surrounding tissue. Video of the vasculature is displayed to the user in a portable headset. The headset and display combination facilitates both visualization in the display and an open field of view directly to the subject's anatomy and practitioner's surroundings. The goal is to provide a non-diagnostic, enhanced visual aide that is used alongside standard visual and tactile methodology. The primary and secondary objectives of this validation are as follows: 1. Primary Objective: To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye. 2. Secondary Objective: To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular structures over the naked eye. Validation Ancillary Endpoints 1. To gather data to demonstrate that the VTS1000 is portable, affords conventional vascular access methods, and provides flexibility, fit and balance during use.

Conditions
COMPLETED
Effect of Brimonidine Tartrate Ophthalmic Solution 0.15% on Pupil Diameter in Normal Eyes
Description

The objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic solution 0.15% (Alphagan P) on pupil diameter under different luminance conditions.

Conditions
COMPLETED
Magnetic Resonance Imaging to Study the Normal Eye
Description

This study will assess the value of improved magnetic resonance imaging (MRI) techniques to study the lens of the human eye. Knowledge of how cataracts develop and progress has been hampered by the lack of human tissue available for study; MRI may provide an effective means for learning more about this eye disease. Normal volunteers between 18 and 70 years of age may be eligible for this study. Participants will undergo a medical history and complete eye examination, including vision assessment, eye pressure measurement, lens and retina examinations, and photography of the eye. MRI scans will be scheduled for a second visit. For this procedure, the volunteer's pupils are dilated and he or she then lies on a stretcher that is moved into a cylinder containing a magnetic field. A device similar to a welder's helmet is placed on the head. Attached to the device are an imaging probe and a small blinking light. The probe receives radio signals from the eye that a computer converts into images. During imaging, the participant gazes at the blinking light; this helps keep the eyes from blinking and wandering. Scan times vary from 2 to 10 minutes; the total time for the study is less than an hour.

COMPLETED
Agreement and Precision Study of UNITY® DX and a Comparator Biometer
Description

The purpose of this study is to validate the clinical measurement performance of an investigational biometer. Subjects will undergo multiple measurements of the eye, and the agreement, repeatability, and reproducibility of the biometric measurements will be evaluated.

ACTIVE_NOT_RECRUITING
P200TE US Reference Database Study
Description

The objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE.

Conditions
COMPLETED
IMOvifa Perimeter Reference Database
Description

This study will collect data to establish a reference database for the IMOvifa perimeter.

Conditions
COMPLETED
Performance Evaluation of OCT and OCT Angiography-based Ocular Measurements (Optical Coherence Tomography)
Description

The purpose of this study is to assess performance of measurements of anatomical and vascular structures of the eye based on OCT and OCTA scans in normal subjects and eyes with pathology.

COMPLETED
Precision of OCT and OCTA-based Ocular Measurements
Description

Precision of OCT- and OCTA-based Ocular Measurements

COMPLETED
Comparison of OCT and OCTA-based Ocular Measurements to Those of Predicate
Description

Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate

COMPLETED
TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
Description

The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.

COMPLETED
OCT Agreement and Precision Study
Description

To demonstrate clinical substantial equivalence of 3D OCT-1 Maestro as comparable to the commercially available iVue and NW-300. Also, to demonstrate clinical substantial equivalence of 3D OCT-2000 Maestro as comparable to the commercially available NW-300.

COMPLETED
A Comparison of the Safety and Comfort of AC-170
Description

The purpose of this study is to evaluate the safety and comfort of AC-170 compared to a placebo.

COMPLETED
Agreement and Precision Study
Description

To evaluate the performance of pachymetry function

COMPLETED
Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
Description

Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations

COMPLETED
The Heidelberg Engineering ANTERION Imaging Agreement Study
Description

This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess image quality of acquired biometry images of the eye

TERMINATED
Evaluation of the Repeatability and Reproducibility of OCTA Image Quality With the Heidelberg Engineering SPECTRALIS With OCT Angiography Module
Description

Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering SPECTRALIS

COMPLETED
Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module
Description

Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.

COMPLETED
TopQ Cut-off Determination Study For 3D-OCT 1 Maestro and 3D OCT-2000
Description

To determine optimal cut-off value for the TopQ cut-off on the Maestro and 3D OCT-2000.

Conditions
COMPLETED
OCT Agreement and Crossed Precision Study
Description

The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance to the RS-3000, assess the crossed precision of each study device and to assess the transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000 Advance.

COMPLETED
TopQ Cut-Off Determination Study
Description

To determine optimal cut-off value for TopQ cut-off.

Conditions
UNKNOWN
Comprehensive Evaluation of Visual Function
Description

The purpose of this study is to assess the level of visual functioning in patients with various eye conditions while wearing different types of eyeglasses.

Conditions
COMPLETED
Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue
Description

The purpose of this study is to understand the effect of Ginkgo Biloba oral supplements on retinal and choroidal ocular tissue.

Conditions
COMPLETED
Effect of Topical Phenylephrine 2.5% on EVP in Normal Human Eyes
Description

Phenylephrine hydrochloride ophthalmic solution is an alpha-1 adrenergic receptor agonist commonly used topically for dilation prior to ocular fundus examination. In the eye, phenylephrine acts locally as a potent vasoconstrictor and mydriatic by constricting ophthalmic blood vessels and the radial dilator muscle of the iris. Episcleral venous pressure (EVP) is a determinant of intraocular pressure (IOP) and can be measured non-invasively by venomanometry. Since phenylephrine is a vasoconstrictor, it may affect episcleral venous tone, but the effect on EVP is unknown. Understanding the physiology of episcleral veins helps us in better understanding of pathophysiology of glaucoma.

COMPLETED
FORE-SIGHT Tissue Oximeter During Cardiac Surgery
Description

The purpose of this study is to measure cerebral and lower extremity oximetry on patients during cardiac surgery.

COMPLETED
Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression
Description

The purpose of this study was to compare the fit and comfort of two types of contact lenses.

Conditions
COMPLETED
Ocular Tissue Levels of 1.5% Levofloxacin Ophthalmic Solution Compared to an Active Comparator
Description

Compare ocular tissue levels following topical ocular instillation of 1.5% levofloxacin ophthalmic solution or an active comparator in subjects undergoing cataract surgery.

Conditions
UNKNOWN
Ultrasonic Evaluation of Ocular Tissues
Description

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.

COMPLETED
Study of Eye Tissue for Sarcoidosis
Description

The purpose of this study is to develop a relatively simple, accurate method of diagnosing sarcoidosis. Sarcoidosis is a disease in which granulomas (nodules of inflamed tissue) develop in various organs, such as the lungs, liver, skin and eyes. Disease symptoms vary depending on the tissues involved. Many patients develop uveitis (eye inflammation). Tissue biopsy-often a costly and difficult invasive procedure-is currently the only definitive diagnostic test for sarcoidosis. Other tests, such as blood and urine tests, do not provide definitive results. Patients with uveitis that is 1) known to be due to sarcoidosis; 2) suspected to be due to sarcoidosis based on specific diagnostic criteria; and 3) known not to be due to sarcoidosis may be enrolled in this study. Participants will undergo an eye examination, blood tests, chest X-ray, and skin test for tuberculosis and other infections. Small tissue samples from the conjunctiva (the thin lining covering the outside of the eye and the inside of the eyelid) and the lacrimal (tear) gland will be taken after the eye is numbed with anesthetic drops and injection. Investigators will examine and compare levels of certain proteins in the biopsied tissues from the three patient groups to see if elevated levels of these substances may indicate granuloma formation. Development of a new, relatively simple diagnostic test for sarcoidosis based on these findings may permit doctors to start appropriate therapy earlier in the course of disease without invasive biopsy.

Conditions
COMPLETED
Analysis of Eye Tissue
Description

The purpose of this investigation is to better understand the inflammatory process that occurs in uveitis (eye inflammation) through study of eye tissues. Patients with uveitis sometimes develop cataracts (clouding of the lens of the eye) or clouding of the vitreous-the gel-like material behind the lens-that can impair eyesight. Those who require cataract surgery or vitrectomy are eligible for this study. Samples of eye tissue and fluid normally removed during standard surgical procedures for these conditions will be given to researchers instead of discarded, as is usually done. Before surgery, patients will undergo routine preoperative tests, including chest X-ray, electrocardiogram, blood tests and urinalysis. They will also have an eye examination and photographs taken of the retina. Other tests that may be performed include fluorescein angiography to evaluate the blood vessels of the retina; ultrasound to examine the back of the eye; and a gallium scan to evaluate inflammation. Immune cells in the blood and eye tissue will be compared and categorized by disease. The eye fluid will be examined for substances involved in the inflammatory process. These studies may provide information that will lead to improved methods of diagnosis and treatment.

COMPLETED
Clinical Validation Study for iVue
Description

To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.