Fluorescein Angiography With a Full-dose Versus a Half-dose of Intravenous Fluorescein
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 10/19/2018 |
| Start Date: | April 5, 2018 |
| End Date: | July 1, 2019 |
| Contact: | Sarah Syeda, MD |
| Email: | ssyeda@med.wayne.edu |
| Phone: | 313-577-7615 |
Comparison of Timing and Image Quality of Different Phases of Optos Fluorescein Angiography Between Two Doses of Intravenous Fluorescein: 250mg Versus 500mg
Fluorescein angiography is a common procedure used in ophthalmology to diagnose and monitor
diseases of the eye. The standard dose of fluorescein dye used in fluorescein angiography is
500mg. It is common practice to give patients who have previously had an adverse reaction to
fluorescein dye a half-dose, or 250mg, of fluorescein. It has been determined by our
institution that anecdotally, there is no difference in image quality between the images
created by a half-dose of fluorescein versus a full dose of fluorescein. Therefore, this
study seeks to determine whether these doses are actually equivalent in terms of image
quality. Patients who consent to participate in the study will be randomized to receive
either a half or a full dose of intravenous fluorescein, and their images will be compared
objectively using image correlation technology, and subjectively using a masked team of
retinal surgeons. We hypothesize that there will be no significant difference between the
images obtained using a half-dose versus a full dose of intravenous fluorescein.
diseases of the eye. The standard dose of fluorescein dye used in fluorescein angiography is
500mg. It is common practice to give patients who have previously had an adverse reaction to
fluorescein dye a half-dose, or 250mg, of fluorescein. It has been determined by our
institution that anecdotally, there is no difference in image quality between the images
created by a half-dose of fluorescein versus a full dose of fluorescein. Therefore, this
study seeks to determine whether these doses are actually equivalent in terms of image
quality. Patients who consent to participate in the study will be randomized to receive
either a half or a full dose of intravenous fluorescein, and their images will be compared
objectively using image correlation technology, and subjectively using a masked team of
retinal surgeons. We hypothesize that there will be no significant difference between the
images obtained using a half-dose versus a full dose of intravenous fluorescein.
Fluorescein angiography is a common procedure used in ophthalmology to diagnose and monitor
diseases of the retinal and choroidal blood vessels. The most commonly seen adverse reactions
to fluorescein angiography include nausea, vomiting, and urticaria. More severe reactions
such as anaphylaxis are rare, occurring in only 1 of 2247 patients (0.4%) in a recent
retrospective study. The standard dose of intravenous fluorescein used for fluorescein
angiography is 500mg given intravenously in a 10% or 25% solution. One study from 2008
attempted to compare a 200mg dose versus a 500mg dose of intravenous fluorescein, and found
that 200mg produced inferior image quality. However, the quality of the cameras used for
fluorescein angiography has improved significantly in the last 10 years, and the scanning
laser ophthalmoscope currently used for fluorescein angiography in our clinic (Optos) is
significantly more effective than the fundus camera used in the 2008 study (Topcon). The
scanning laser ophthalmoscope uses a fundamentally different imaging technique than the
traditional fundus camera, with a much narrower illumination source, and has been shown to be
significantly more sensitive in the detection of retinal vascular leakage.
A commonly used method for preventing adverse reactions in patients who have previously had
an adverse reaction to intravenous fluorescein is to use a 250mg dose instead of the standard
500mg dose, despite the lack of evidence to this effect. In our anecdotal experience, a 250mg
dose of intravenous fluorescein, used in patients whom have previously experienced an adverse
reaction, has produced images of equivalent quality to the images produced using a full 500mg
dose. To our knowledge, no study has compared a 500mg dose of intravenous fluorescein with a
lower dose since the 2008 study previously mentioned, despite the advances in camera quality.
The study will aim to recruit a sample size of approximately 100 patients. Adult patients
scheduled for fluorescein angiography at the Kresge Eye Institute will be recruited into the
study by one of the study members if they meet inclusion and exclusion criteria. Once a
patient has consented to participate in the study, they will be randomized to receive either
a 250mg or 500mg dose of intravenous fluorescein with their fluorescein angiography
procedure. All fluorescein angiograms will be done only if clinically indicated, and
therefore the patient will not be placed at any increased risk by participating in this
study. If a participant returns for a repeat fluorescein angiogram within the next four
months, they will receive the dose (250mg or 500mg) which they did not receive with their
previous angiogram. Patients who experience an adverse reaction during their first angiogram
will be removed from the study in order to prevent a patient who had an adverse reaction with
a half-dose from receiving a full-dose with a subsequent procedure. The photographer will
adjust the image brightness settings in order to create the "best possible" image for each
patient, and there will be no change between procedures with the 250mg and 500mg doses. A
single camera (Optos) will be used for each patient in the study.
Data collection will be obtained from the patient, the imaging procedure, and the patient's
electronic medical records at the Kresge Eye Institute. Information to be collected includes
age, gender, race, visual acuity, and ophthalmologic medical history. The timing and quality
of images at different phases of fluorescein angiography will be compared between 500mg and
250mg doses in each eye using objective and subjective measures. To objectively compare the
quality of images between the two doses, the level of correlation between images obtained
from 250mg and 500mg doses will be measured. Subjective criteria will include grading of the
images by a panel of masked retinal surgeons. These objective and subjective criteria will
then be used to determine whether any appreciable difference exists in the image quality
between 250mg and 500mg doses of intravenous fluorescein given prior to Optos fluorescein
angiography.
diseases of the retinal and choroidal blood vessels. The most commonly seen adverse reactions
to fluorescein angiography include nausea, vomiting, and urticaria. More severe reactions
such as anaphylaxis are rare, occurring in only 1 of 2247 patients (0.4%) in a recent
retrospective study. The standard dose of intravenous fluorescein used for fluorescein
angiography is 500mg given intravenously in a 10% or 25% solution. One study from 2008
attempted to compare a 200mg dose versus a 500mg dose of intravenous fluorescein, and found
that 200mg produced inferior image quality. However, the quality of the cameras used for
fluorescein angiography has improved significantly in the last 10 years, and the scanning
laser ophthalmoscope currently used for fluorescein angiography in our clinic (Optos) is
significantly more effective than the fundus camera used in the 2008 study (Topcon). The
scanning laser ophthalmoscope uses a fundamentally different imaging technique than the
traditional fundus camera, with a much narrower illumination source, and has been shown to be
significantly more sensitive in the detection of retinal vascular leakage.
A commonly used method for preventing adverse reactions in patients who have previously had
an adverse reaction to intravenous fluorescein is to use a 250mg dose instead of the standard
500mg dose, despite the lack of evidence to this effect. In our anecdotal experience, a 250mg
dose of intravenous fluorescein, used in patients whom have previously experienced an adverse
reaction, has produced images of equivalent quality to the images produced using a full 500mg
dose. To our knowledge, no study has compared a 500mg dose of intravenous fluorescein with a
lower dose since the 2008 study previously mentioned, despite the advances in camera quality.
The study will aim to recruit a sample size of approximately 100 patients. Adult patients
scheduled for fluorescein angiography at the Kresge Eye Institute will be recruited into the
study by one of the study members if they meet inclusion and exclusion criteria. Once a
patient has consented to participate in the study, they will be randomized to receive either
a 250mg or 500mg dose of intravenous fluorescein with their fluorescein angiography
procedure. All fluorescein angiograms will be done only if clinically indicated, and
therefore the patient will not be placed at any increased risk by participating in this
study. If a participant returns for a repeat fluorescein angiogram within the next four
months, they will receive the dose (250mg or 500mg) which they did not receive with their
previous angiogram. Patients who experience an adverse reaction during their first angiogram
will be removed from the study in order to prevent a patient who had an adverse reaction with
a half-dose from receiving a full-dose with a subsequent procedure. The photographer will
adjust the image brightness settings in order to create the "best possible" image for each
patient, and there will be no change between procedures with the 250mg and 500mg doses. A
single camera (Optos) will be used for each patient in the study.
Data collection will be obtained from the patient, the imaging procedure, and the patient's
electronic medical records at the Kresge Eye Institute. Information to be collected includes
age, gender, race, visual acuity, and ophthalmologic medical history. The timing and quality
of images at different phases of fluorescein angiography will be compared between 500mg and
250mg doses in each eye using objective and subjective measures. To objectively compare the
quality of images between the two doses, the level of correlation between images obtained
from 250mg and 500mg doses will be measured. Subjective criteria will include grading of the
images by a panel of masked retinal surgeons. These objective and subjective criteria will
then be used to determine whether any appreciable difference exists in the image quality
between 250mg and 500mg doses of intravenous fluorescein given prior to Optos fluorescein
angiography.
Inclusion Criteria:
- Adult patients scheduled for fluorescein angiography at Kresge Eye Institute.
Exclusion Criteria:
- Patients with known major profusion defects on fluorescein angiography.
- Patients with prior adverse reactions to fluorescein angiography.
- Patients with significant photophobia as judged by the photographer.
- Patients with visually significant cataracts.
We found this trial at
1
site
Detroit, Michigan 48201
Principal Investigator: Gary W. Abrams, MD
Phone: 313-577-7615
Click here to add this to my saved trials
