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.
RCT Entities:
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.
Authors: Muhammad W Shahid; Julia E Crook; Alexander Meining; Aymeric Perchant; Anna Buchner; Victoria Gomez; Michael B Wallace Journal: J Interv Gastroenterol Date: 2011-10-01
Authors: Esmee Iml Liem; Jan Erik Freund; Joyce Baard; D Martijn de Bruin; M Pilar Laguna Pes; C Dilara Savci-Heijink; Ton G van Leeuwen; Theo M de Reijke; Jean Jmch de la Rosette Journal: JMIR Res Protoc Date: 2018-02-07