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This study aims to compare the efficacy and safety of fluorescein angiography using 1mL versus 3mL of 10% fluorescein dye.
The investigators will recruit patients who need fluorescein angiography for their retinal diseases.
The investigators will collect data on image quality and complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Na Fluorescein 3mL Arm | Active Comparator | Participants in this arm will receive Na Fluorescein 10% Inj 3mL (300mg) before taking fluorescein angiography. |
|
| Na Fluorescein 1mL Arm | Experimental | Participants in this arm will receive Na Fluorescein 10% Inj 1mL (100mg) before taking fluorescein angiography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescein Sodium | Drug | Patients will receive Fluorescein Sodium 3mL (300mg) or 1mL (100mg) intravenously prior to fluorescein angiography. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18982034 | Background | 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. | |
| 18717436 | Background | 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. |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019793 | Fluorescein |
| ID | Term |
|---|---|
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| One month |
| Complication | frequency of complication of fluorescein angiography will be compared between two groups | immediately after the test |
| 3377048 | Background | 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. |
| 39933138 | Derived | 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. |
| D009930 |
| Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |