Prospective Cohort Study on Predicting the Progression of Diabetic Microangiopathy Using Multimodal Eye Imaging

Обзор

To develop an artificial intelligence (AI) model to predict DR progression based on a prospective cohort database.With use of an innovative AI model and a validated machine learning algorithm, based on multimodal vascular and neuro imaging of the eye, the progression of diabetic microangiopathy especially the DR could successfully be predictse and fundamentally facilitate diabetes management.

Подробное описание

To develop an artificial intelligence (AI) model to predict DR progression based on a prospective cohort database.This study will first conduct a prospective single-center cohort, which will enroll 250 type 2 diabetes mellitus patients with non-proliferative diabetic retinopathy (NPDR). The follow-up time points will be 3 months, 6 months, 1 year, 2 years, and 3 years after enrollment or reaching the endpoint (any condition that needs retinal photocoagulation, anti-vascular endothelial growth factor injections, and pars plana vitrectomy). The study will collect both patient clinical characteristics and multi-model eye imaging. With use of an innovative AI model and a validated machine learning algorithm, based on multimodal vascular and neuro imaging of the eye, the progression of diabetic microangiopathy especially the DR could successfully be predictse and fundamentally facilitate diabetes management.

Первичные конечные точки

• DRSS Score and Classification [Срок оценки: At Enrollment]

Вторичные конечные точки (2)

• Renal Function Test [Срок оценки: At Enrollment]
• Peripheral Neuropathy Assessment [Срок оценки: At Enrollment]

Критерии участия

Критерии включения

• (1) age between 40 and 80 years, regardless of gender, (2) meet the diagnostic criteria of T2DM based on the Standards of Medical Care in Diabetes (2021)11, and complete evaluation at the Endocrinology Department of Peking University Third Hospital, (3) meet the Diabetic Retinopathy Severity Scale (DRSS) score level of mild to moderate-severe NPDR (i.e. 35 ≤ DRSS level ≤ 60, as shown in eTables 1 \& 2 in the Supplement) based on the montages ultra-widefield (UWF) fundus photographs,12 without clinically significant macular edema (CSME, defined as one or more of the followings: retinal thickening at or within 500 μm of the center of the macula; hard exudates at or within 500 μm of the center of the macula, if associated with adjacent retinal thickening; or a zone or zones of retinal thickening one disc area in size, at least part of which is within one disc diameter of the center of the macula),13 (4) willing to sign the informed consent form.

Критерии исключения

• (1) conjunctivitis, keratitis, blepharitis, episcleritis, scleritis, uveitis, severe dry eye disease, using anti-glaucoma eyedrops, or any condition causing conjunctival congestion or ciliary congestion, (2) pterygium, wearing contact lens in the past week, ocular surface burn, conjunctival tumors, or any condition causing significant conjunctival vascular deformities, (3) previously undergone intraocular surgeries involving manipulation of the conjunctiva, or corneal refractive surgery, (4) history of hematological disorder, dysthyroidism, rheumatic disorder, malignant tumor, (5) refractive media opacity resulting in poor visualization of fundus photographs, (6) difficulty in maintaining fixation or comprehension, making it challenging to cooperate with the examination, (7) difficulty in completing follow-up visits in 3 years.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT06727955 · M2023514

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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