Trials Sponsors Conditions Drugs Pricing

Conditions

Retinal Disease

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

Objective vessel intensity
One month
Complication
immediately after the test

Study Arms (2)

Na Fluorescein 3mL Arm

ACTIVE COMPARATOR

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

Drug: Fluorescein Sodium

Na Fluorescein 1mL Arm

EXPERIMENTAL

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

Drug: Fluorescein Sodium

Interventions

Fluorescein SodiumDrug

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

Na Fluorescein 1mL ArmNa Fluorescein 3mL Arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients who required an fluorescein angiography for their retinal diseases (eg. diabetic retinopathy, retinal vein occlusion, etc.)

You may not qualify if:

Sponsors & Collaborators

Seoul National University Bundang Hospital
Otherlead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Related Publications (4)

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.
PMID: 18982034BACKGROUND
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.
PMID: 18717436BACKGROUND

MeSH Terms

Conditions

Retinal Diseases

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

FluoresceinsSpiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsXanthenesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Enrollment

144 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: DIAGNOSTIC
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 23, 2022

Study Start

February 1, 2023

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Na Fluorescein 3mL Arm

Na Fluorescein 1mL Arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Na Fluorescein 3mL Arm

Na Fluorescein 1mL Arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations