Search for abnormalities of fundus blood vessels in moyamoya disease

JRCT ID: jRCTs031200402

Registered date:08/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Moyamoya disease
• Date of first enrollment: 23/04/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): For fluorescein fundus angiography, 500 mg of fluorescein (5 ml vial of aqueous solution containing 500 mg of fluorescein) and 25 mg of Ophthagreen (2 ml of blue indocyanine green) are dissolved in 2 ml of distilled water for injection and injected through the forearm of the elbow vein. In daily practice, diabetic retinopathy can be treated by using a diabetic retinal imaging system (optos). In daily practice, it is used for the diagnosis of diabetic retinopathy, uveitis, occlusive retinal vascular disease, and age-related macular degeneration.

Outcome(s)

• Primary Outcome: Prevalence of Retinal Vasculature Abnormalities in Patients with Moyamoya Disease on Fluorescence Fundus Angiography
• Secondary Outcome: Retinal blood vessel density, area of central fovea no-reflux area, subcentral foveal retinal thickness, and subcentral foveal choroidal thickness obtained from retinal optical coherence tomography and retinal optical coherence angiography will be compared between groups of patients with moyamoya disease and normal fundus.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Moyamoya disease patient group
1) Patients diagnosed with moyamoya disease (regardless of stage)
2) Patients aged 20 years or older (regardless of gender)
3) Patients with no previous history of fundus vascular disease
4) Outpatients
5) Patients who have given written consent to participate in this study.

Normal fundus group
1) Patients who have undergone general ophthalmologic examination (visual acuity test, refraction test, intraocular pressure test, anterior segment and fundus examination), fundus photography, retinal optical coherence tomography, retinal optical coherence angiography, and laser speckle flow graphing examination at our ophthalmology department.
2) Patients who do not have fundus lesions in one or both eyes based on the above tests.
3) Patients who are 20 years old or older (regardless of gender)
4) Outpatients

Exclude criteria

Moyamoya disease patient group
1) Patients with a history of hypersensitivity to fluorescein and indocyanine green
2) Patients with a history of iodine hypersensitivity
3) Patients with a history of other serious drug allergies
4) Narrow-angle eyes
5) Pregnant women and lactating women
(6) Patients within 6 months of angina pectoris or myocardial infarction attack
7) Hepatic dysfunction
8) Patients with a history of stroke or cerebrovascular surgery within 6 months
9) Other patients who are judged by the physician to be inappropriate for the study.

Normal fundus group
(1) Patients who do not wish to cooperate in the research by disclosing the research information through opt-out

Related Information

• Primary Sponsor: Akiyama Hideo
• Source(s) of Monetary Support: Eisai Co., Ltd