NCT05664555

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

December 6, 2022

Last Update Submit

April 15, 2024

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

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:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

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

  • 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.

    PMID: 3377048BACKGROUND

  • Song SH, Joo K, Woo SJ, Kim MS. IMAGE QUALITY AND SAFETY OF 300 MG VERSUS 100 MG FLUORESCEIN IN ULTRA-WIDEFIELD FLUORESCEIN ANGIOGRAPHY: A Randomized Clinical Trial. Retina. 2025 Jun 1;45(6):1168-1174. doi: 10.1097/IAE.0000000000004420.

    PMID: 39933138DERIVED

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 CompoundsPolycyclic Compounds

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

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations

KR(1)