NEWS HIGHLIGHTS
Published Studies Related to Fluorescite (Fluorescein Ophthalmic)
Evaluation of the side effects and image quality during fluorescein angiography comparing 2 mL and 5 mL sodium fluorescein. [2008.10]
BACKGROUND: Although intravenous fluorescein angiography (IVFA) is a relatively safe procedure, side effects have been shown to occur. The designed purpose of this study was to demonstrate a reduction in the frequency and severity of side effects during digital IVFA using 2 mL compared with 5 mL of 10% sodium fluorescein (NaFl). The secondary hypothesis was to show that no loss of image quality occurred with a reduction in the NaFl dose utilizing digital fluorescein angiography... INTERPRETATION: Two millilitres of NaFl for IVFA produces inferior quality digital images compared with 5 mL of NaFl. The potential reduction in adverse events associated with 2 mL of NaFl becomes unimportant in light of this significant finding regarding image quality.
Validity of fluorexon disodium versus sodium fluorescein for use in Goldmann tonometry. [2006.07]
PURPOSE: To evaluate the safety, validity, and comfort of 0.35% fluorexon disodium and 0.4% benoxinate (Flura-Safe) compared with the gold standard of 0.25% sodium fluorescein and 0.4% benoxinate for Goldmann applanation tonometry (GAT)... CONCLUSION: Not only was the new fluorexon product accurate and effective in GAT, it was also statistically more comfortable and had a less stinging and burning effect at 1 minute after drop instillation than the traditional fluorescein formulation. Because fluorexon is less likely to stain soft contact lenses, this may be the dye-anesthetic formulation of choice for practices that routinely perform GAT.
Bioavailability of fluorescein from a new drug delivery system in human eyes. [2004.01]
AIM: To assess the ocular bioavailability of fluorescein from a novel drug delivery system compared with one single preservative free eye drop... CONCLUSION: A significantly better bioavailability was achieved in human eyes by using lyophilisate compared with the same dose from a conventional eye drop. Lyophilisates are a favourable alternative to conventional eye drops since they have no preservatives, higher long term stability, no pH adjustment, and easy handling.
Evaluation of intravenous fluorescein in intradermal allergy testing in psittacines. [2003.12]
This study was designed to improve the clinical feasibility of intradermal skin testing of psittacine birds using intravenous fluorescein stain. Twenty-five healthy, anaesthetized Hispaniolan Amazon parrots (Amazona ventralis) were injected intravenously with 10 mg kg-1 fluorescein-sodium 1% followed by intradermal injections of 0.02 mL phosphate-buffered saline, histamine phosphate (1:100,000 w/v) and codeine phosphate (1:100,000 w/v) at the sternal apteria...
Lyophilisates for drug delivery in ophthalmology: pharmacokinetics of fluorescein in the human anterior segment. [2002.10]
AIMS: To assess the ocular bioavailability of fluorescein from a novel water free, freeze dried ophthalmic drug delivery system compared to conventional preservative-free fluorescein eye drops... CONCLUSION: The greater intraocular bioavailability of fluorescein from the lyophilisate relative to the solution suggests that it may be a useful method for delivering substances to the eye.
Clinical Trials Related to Fluorescite (Fluorescein Ophthalmic)
Flourescein for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I and II Malignant Melanoma [Recruiting]
The purpose of this research study is to use two different drugs to find where melanoma
might spread and to remove these tissues. We believe that tumor cells from the melanoma
first move through the lymphatic system (a system of clear fluid that moves around the body
and carries white blood cells, much like the blood system) to a lymph node in an orderly
way. If we can identify the first lymph nodes to receive a tumor cell, this can be removed
and examined. We currently use one drug, called "technetium-99m sulfur colloid" which can
detect about 90% of the first lymph nodes that the tumor cells would move to.
Technetium-99m is a radioactive compound and can be detected through the skin by a special
instrument that reads radioactivity. As part of this research, we would like to use a
second drug called "fluorescein" (Fluorescite®) to see if it will identify the same lymph
nodes or additional ones and examine these. This drug is fluorescent and can be detected
even through the skin using a blue light. This drug is approved by the Federal Drug
Administration (FDA) to for injection in the vein as a diagnostic aid and has been safely
used in people for many years. In this study, we will be injecting it under the skin, which
is a different use from how it is currently approved by the FDA. In the past another drug
has been used, called "isosulfan blue" (Lymphazurin®), but availability of this drug is
currently limited, and it has higher risks associated with it.
This study is being conducted by Dr. Robert Andtbacka, Dr. Dirk Noyes, Dr. James McGreevy
and at University of Utah. This study is a Phase I/II and is done to find out if the drug
can be used safely when given under the skin and if it will work for this purpose.
Corneal Topographer Fluorescein Patterns [Recruiting]
The objective of this study is to determine if corneal topography can be used to predict the
fluorescein pattern of keratoconus lenses on the eye. A corneal topography image will be
taken and the computer selected lens will be placed on the eye. After placement of the lens
color photographs will be taken of the eye's fluorescein pattern and compared to the
computer predicted pattern.
Keratometric and Fluorescein Tear Breakup Time [Recruiting]
The purpose of the research is to determine if putting fluorescein onto the eye (most common
test done for dry eye syndrome) is an accurate way to measure dry eye symptoms. The
investigators can avoid placing any foreign substance into the eye by using a manual
keratometer. Therefore, the investigators want to compare the measurements of tear break up
time using fluorescein with using a manual keratometer and then compare these measurements
to a validated dry eye symptoms questionnaire.
Measuring tear break up time using a manual keratometer is a better way to estimate dry eye
symptoms than using fluorescein to measure tear break up time.
Confocal Laser Endomicroscopy [Recruiting]
Confocal laser endomicroscopy (CLE) is a new diagnostic technique that allows microscopic
examination of the digestive mucosa during ongoing endoscopy. Different types of tissue and
diseases can be diagnosed immediately, and analysis of the in vivo microarchitecture is
helpful to better target standard biopsies and reduce the number of biopsies required. CLE
necessitates an intravenous injection of a fluorescent marker, e. g. fluorescein, to obtain
'optical biopsies' with a high level of magnification (up to 1000 fold). To date, more than
1000 endomicroscopy procedures have been performed in the world and different publications
have shown the safety, feasibility and excellent diagnostic yield of CLE. No complication
related to IV injection of fluorescein has been reported. However, all these data come from a
very limited number of expert centres and need to be confirmed and validated at the
multicenter level. The aims of this multicenter trial are: 1) To standardize CLE in all
centres equipped in France, 2) To ensure the safety of intravenous fluorescein injection, 3)
To test the diagnostic value of CLE in various conditions representative of the large
spectrum of different cancerous and non-cancerous digestive diseases
Injected Ranibizumab to Treat Macular Telangiectasia With New Blood Vessel Formation [Recruiting]
This study will examine whether the drug ranibizumab is an effective treatment for macular telangiectasia, a condition in which existing blood vessels near the macula (the back part of the eye responsible for sharp central vision) become dilated and twisted, and new abnormal blood vessels may form under the retina. Both the existing dilated vessels, as well the new subretinal vessels can leak fluid and blood, distort the retina, and affect vision. This study will see if ranibizumab can slow or stop the leakage and growth of new vessels forming under the retina.
Patients 18 years of age and older who have macular telangiectasia in both eyes and new blood vessel formation under the retina in at least one eye may be eligible for this study. Visual acuity must be 20/40 or worse.
Participants receive at least four injections of ranibizumab into the eye over a 12-week period. After the fourth injection, additional injections may be given every 4 weeks for up to 1 year if the doctor determines that they may be of benefit. In addition to ranibizumab treatment, patients undergo the following procedures:
- Medical history and physical examination.
- Eye examination, including dilation of the pupils and measurement of the fluid pressure in the eye.
- Fluorescein angiogram: A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Photographs of the retina are taken with a special camera that flashes a blue light into the eye. The photos show whether any dye has leaked from the vessels into the retina.
- Indocyanine green angiography: This procedure identifies feeder vessels that may be supplying the abnormal blood vessels. The test is similar to fluorescein angiography, but uses a green dye and flashes an invisible light.
- Autofluorescence imaging: This test examines how well the retina functions. The back of the eye is photographed with a bright light.
- Optical coherence tomography: This test measures retinal thickness. A light shined into the eye produces cross-sectional pictures of the retina. The measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same.
- Stereoscopic color fundus photography: The pupils are dilated and special photographs of the inside of the eye are taken to evaluate the retina and measure changes that occur over time. The camera flashes a bright light into the eye for each picture.
- Follow-up visits: The doctor evaluates the effects of the study treatment before and after each injection. Patients are contacted by phone 3 days after each injection to check on any treatment side effects. A final follow-up visit is scheduled 8 weeks after the last treatment.
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