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

Phase 4

Completed

• Conditions: Retinal Disease
• Interventions: Drug: Fluorescein Sodium

• Registration Number: NCT05664555
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-23
• Study Start: 2023-02-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Na Fluorescein 3mL Arm	Fluorescein Sodium	Participants in this arm will receive Na Fluorescein 10% Inj 3mL (300mg) before taking fluorescein angiography.
Na Fluorescein 1mL Arm	Fluorescein Sodium	Participants in this arm will receive Na Fluorescein 10% Inj 1mL (100mg) before taking fluorescein angiography.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of