Intraoperative fluorescein angiography using an ophthalmic endoscope

JRCT ID: jRCTs041190078

Registered date:14/11/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetic retinopathy. Uveitis. Age-related macular degeneration. Rubeotic glaucoma.
• Date of first enrollment: 14/11/2019
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Evaluate the presence or absence of neovacular and non perfusion area between the preoperative fluorescein angiography (FA) images and the intraoperative endoscopic FA images by using the findings score.

Outcome(s)

• Primary Outcome: Evaluate the presence or absence of neovacular and non perfusion area between the preoperative fluorescein angiography (FA) images and the intraoperative endoscopic FA images by using the findings score.
• Secondary Outcome: Safety of the intraoperative endoscopic fluoresein angiography test.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

Patients who sufficiently understand this study, agree to participate in this study after receiving sufficient explanation and obtain written informed consent under their own will.
Patients older than 20 and under 85 years old at the time of informed consent acquisition.
Patients whose blood circulation evaluation by intraoperative fluorescein angiography (FA) using an ophthalmic endoscope are thought to be useful, and who require intraocular surgery.
Specifically, the following patients.
Patients with difficulty in evaluating the fundus with normal FA test due to small pupil, severe cataract, vitreous hemorrhage or vitreous opacity. Or patients who may have neovascular or non perfusion area in the peripheral retina, under the retina, at the back of the iris, or at angle that can not be visualized by normal FA test, subjects are shown below.
- Diabetic retinopathy
- Uveitis
- Familial exudative vitreoretinopathy
- Retinal detachment secondary to atopic dermatitis, uveitis or retinal vein occlusion
- Age related macular degeneration
- Neovascular glaucoma
- Secondary glaucoma

Exclude criteria

Patients who previously examined FA test and have experienced adverse reactions or poor physical condition due to contrast media.
Patients who previously had severe food or drug allergies.
Patients who have severe hepatic dysfunction.
Patients who have severe hypertension (grade III hypertension).
Pregnant woman, maternal, lactating woman.
Patients who show the following abnormalities in screening tests.
- Systolic blood pressure is higher than 180 mmHg or diastolic blood pressure is more than 120 mmHg.
- AST or ALT is higher than 100 IU/L.
Patients who are considered inappropriate to participate in this study by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Kaga Tatsushi