Dose Optimization for Safe and Efficient Fluorescein Angiography (DOSE Study)

Retinal Disease Clinical Trial

— DOSE  

Official title:

Low Dose Fluorescein Angiography Comparing 1mL and 3mL of 10% Fluorescein: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05664555
• Other study ID #: B-2211-790-004
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare the efficacy and safety of fluorescein angiography using 1mL versus 3mL of 10% fluorescein dye.

Description:

The investigators will recruit patients who need fluorescein angiography for their retinal diseases. The investigators will collect data on image quality and complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

Intervention

Drug:
• Fluorescein Sodium
Patients will receive Fluorescein Sodium 3mL (300mg) or 1mL (100mg) intravenously prior to fluorescein angiography.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Friberg TR, Gupta A, Yu J, Huang L, Suner I, Puliafito CA, Schwartz SD. Ultrawide angle fluorescein angiographic imaging: a comparison to conventional digital acquisition systems. Ophthalmic Surg Lasers Imaging. 2008 Jul-Aug;39(4):304-11. doi: 10.3928/15428877-20080701-06. — View Citation

Moosbrugger KA, Sheidow TG. Evaluation of the side effects and image quality during fluorescein angiography comparing 2 mL and 5 mL sodium fluorescein. Can J Ophthalmol. 2008 Oct;43(5):571-5. doi: 10.3129/i08-122. — View Citation

Nasrallah FP, Jalkh AE, Trempe CL, McMeel JW. Low-dose fluorescein angiography. Am J Ophthalmol. 1988 Jun 15;105(6):690. doi: 10.1016/0002-9394(88)90071-2. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective image quality from 3 experts	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.	One month
Secondary	Objective vessel intensity	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.	One month
Secondary	Complication	frequency of complication of fluorescein angiography will be compared between two groups	immediately after the test