Dose Optimization for Safe and Efficient Fluorescein Angiography (DOSE Study) (DOSE)
Primary Purpose
Retinal Disease
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fluorescein Sodium
Sponsored by
About this trial
This is an interventional diagnostic trial for Retinal Disease
Eligibility Criteria
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
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Na Fluorescein 3mL Arm
Na Fluorescein 1mL Arm
Arm Description
Participants in this arm will receive Na Fluorescein 10% Inj 3mL (300mg) before taking fluorescein angiography.
Participants in this arm will receive Na Fluorescein 10% Inj 1mL (100mg) before taking fluorescein angiography.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Objective vessel intensity
The intensity of arteries and veins at the same distance from optic disc will be obtained using ImageJ and compared between two dose groups. The mean value of the intensity of vessels will be calculated and compared between the two dose groups.
Complication
frequency of complication of fluorescein angiography will be compared between two groups
Full Information
NCT ID
NCT05664555
First Posted
December 6, 2022
Last Updated
March 13, 2023
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05664555
Brief Title
Dose Optimization for Safe and Efficient Fluorescein Angiography (DOSE Study)
Acronym
DOSE
Official Title
Low Dose Fluorescein Angiography Comparing 1mL and 3mL of 10% Fluorescein: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Na Fluorescein 3mL Arm
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive Na Fluorescein 10% Inj 3mL (300mg) before taking fluorescein angiography.
Arm Title
Na Fluorescein 1mL Arm
Arm Type
Experimental
Arm Description
Participants in this arm will receive Na Fluorescein 10% Inj 1mL (100mg) before taking fluorescein angiography.
Intervention Type
Drug
Intervention Name(s)
Fluorescein Sodium
Intervention Description
Patients will receive Fluorescein Sodium 3mL (300mg) or 1mL (100mg) intravenously prior to fluorescein angiography.
Primary Outcome Measure Information:
Title
Subjective image quality from 3 experts
Description
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.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Objective vessel intensity
Description
The intensity of arteries and veins at the same distance from optic disc will be obtained using ImageJ and compared between two dose groups. The mean value of the intensity of vessels will be calculated and compared between the two dose groups.
Time Frame
One month
Title
Complication
Description
frequency of complication of fluorescein angiography will be compared between two groups
Time Frame
immediately after the test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Seok Kim, MD MSc
Phone
82-31-787-7388
Email
mutjina@hanmail.net
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Seok Kim, MD MSc
Phone
82-31-787-7388
Email
mutjina@hanmail.net
First Name & Middle Initial & Last Name & Degree
Min Seok Kim, MD MSc
12. IPD Sharing Statement
Citations:
PubMed Identifier
18982034
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.
Results Reference
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PubMed Identifier
18717436
Citation
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.
Results Reference
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PubMed Identifier
3377048
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.
Results Reference
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Dose Optimization for Safe and Efficient Fluorescein Angiography (DOSE Study)
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