Retinal Disease
Conditions
Brief summary
This study aims to compare the efficacy and safety of fluorescein angiography using 1mL versus 3mL of 10% fluorescein dye.
Detailed description
The investigators will recruit patients who need fluorescein angiography for their retinal diseases. The investigators will collect data on image quality and complications.
Interventions
Patients will receive Fluorescein Sodium 3mL (300mg) or 1mL (100mg) intravenously prior to fluorescein angiography.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who required an fluorescein angiography for their retinal diseases (eg. diabetic retinopathy, retinal vein occlusion, etc.)
Exclusion criteria
* media opacity (corneal opacity, vitreous hemorrhage grade 2 or more, cataract LOCS III grade 3 or more) * known history of adverse reactions to fluorescein * dilated pupil diameter less than 5 mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective image quality from 3 experts | One month | Images from two dose groups will be compared in terms of central and peripheral image quality. Three retinal experts were masked to the fluorescein dose the patients had received. Each expert graded patients' fluorescein angiography images on a scale of 1 to 5 (1:very poor, 2: poor, 3: average, 4: better than average, 5: excellent) with respect to the subjective quality of the image and aid of making a diagnosis. The mean value of the image quality score will be compared between the two dose groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective vessel intensity | One month | Mean vascular pixel intensity was quantitatively measured using ImageJ (version 1.54f, National Institutes of Health). The 8-bit grayscale image was imported into imageJ and processed with a top-hat filter to suppress the background noise. This UWFA image was divided via a customized grid, consisting of 2 rings centered on the fovea. The mean vascular pixel intensity in each of these zones was then automatically measured using imageJ software. |
| Complication | immediately after the test | frequency of complication of fluorescein angiography will be compared between two groups |
Countries
South Korea
Outcome results
None listed