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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Retinal Disease

Treatments: Drug: Fluorescein Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT05664555

B-2211-790-004

Details and patient eligibility

About

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

Full description

The investigators will recruit patients who need fluorescein angiography for their retinal diseases.

The investigators will collect data on image quality and complications.

Enrollment: 144 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups

Na Fluorescein 3mL Arm

Active Comparator group

Description:

Participants in this arm will receive Na Fluorescein 10% Inj 3mL (300mg) before taking fluorescein angiography.

Treatment:

Drug: Fluorescein Sodium

Na Fluorescein 1mL Arm

Experimental group

Description:

Participants in this arm will receive Na Fluorescein 10% Inj 1mL (100mg) before taking fluorescein angiography.

Treatment:

Drug: Fluorescein Sodium