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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05664555
Other study ID # B-2211-790-004
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 1, 2023
Est. completion date March 31, 2024

Study information

Verified date April 2024
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

The investigators will recruit patients who need fluorescein angiography for their retinal diseases. The investigators will collect data on image quality and complications.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Objective vessel intensity 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. One month
Secondary Complication frequency of complication of fluorescein angiography will be compared between two groups immediately after the test
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