Evaluation of the side effects and image quality during fluorescein angiography comparing 2 mL and 5 mL sodium fluorescein.

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.

METHODS

A prospective study was initiated in which 1200 patients were randomized to 2 mL or 5 mL of 10% NaFl to allow for the evaluation of adverse events. Standard IVFA technique utilizing modern high-resolution digital photography was employed. Photographers evaluated the difficulty of image capture. A masked observer recorded all adverse events. Masked ophthalmologists evaluated image quality subjectively with a 4-point rating scale. Secondary to concerns regarding image quality, a masked interim analysis was carried out after 140 patients had been randomized.

RESULTS

A statistically significant reduction in the quality of angiograms (p = 0.0025) and ease of photography (p = 0.0012) was associated with 2 mL of NaFl, necessitating the termination of the study. Patients randomized to the 5 mL NaFl group experienced all 3 of the minor adverse events in the study. No statistically relevant conclusions could be obtained from this limited group.

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.