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

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

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

Official Title
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Low Dose Fluorescein Angiography Comparing 1mL and 3mL of 10% Fluorescein: A Randomized Controlled Trial

Conditions
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Retinal Disease

Intervention / Treatment
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* Drug: Fluorescein Sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Na Fluorescein 3mL Arm<br>Participants in this arm will receive Na Fluorescein 10% Inj 3mL (300mg) before taking fluorescein angiography. | Drug: Fluorescein Sodium<br>* Patients will receive Fluorescein Sodium 3mL (300mg) or 1mL (100mg) intravenously prior to fluorescein angiography.<br>|
| Experimental: Na Fluorescein 1mL Arm<br>Participants in this arm will receive Na Fluorescein 10% Inj 1mL (100mg) before taking fluorescein angiography. | Drug: Fluorescein Sodium<br>* Patients will receive Fluorescein Sodium 3mL (300mg) or 1mL (100mg) intravenously prior to fluorescein angiography.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One month | 
| Complication | frequency of complication of fluorescein angiography will be compared between two groups | immediately after the test |