Low Dose Fluorescein Angiography Comparing 1mL and 3mL of 10% Fluorescein
Study Details
Study Description
Brief Summary
This study aims to compare the efficacy and safety of fluorescein angiography using 1mL versus 3mL of 10% fluorescein dye.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Na Fluorescein 3mL Arm Participants in this arm will receive Na Fluorescein 10% Inj 3mL (300mg) before taking fluorescein angiography. |
Drug: Fluorescein Sodium
Patients will receive Fluorescein Sodium 3mL (300mg) or 1mL (100mg) intravenously prior to fluorescein angiography.
|
| Experimental: Na Fluorescein 1mL Arm Participants in this arm will receive Na Fluorescein 10% Inj 1mL (100mg) before taking fluorescein angiography. |
Drug: Fluorescein Sodium
Patients will receive Fluorescein Sodium 3mL (300mg) or 1mL (100mg) intravenously prior to fluorescein angiography.
|
Outcome Measures
Primary Outcome Measures
- Subjective image quality from 3 experts [One month]
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 [One month]
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 [immediately after the test]
frequency of complication of fluorescein angiography will be compared between two groups
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | Korea, Republic of | 13620 |
Sponsors and Collaborators
- Seoul National University Bundang Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- B-2211-790-004