Clinical trial NCT06727955: Prospective Cohort Study on Predicting the Progression of Diabetic Microangiopathy Using Multimodal Eye Imaging
Official title: Prospective Cohort Study on Predicting the Progression of Diabetic Microangiopathy Using Multimodal Eye Imaging
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Retinopathy
Keywords: diabetic retinopathy
artificial intelligence model
multimodal eye imaging
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* (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.

Exclusion Criteria:

* (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.

Primary outcomes:
measure: DRSS Score and Classification
timeFrame: At Enrollment
Secondary outcomes:
measure: Renal Function Test
timeFrame: At Enrollment
measure: Peripheral Neuropathy Assessment
timeFrame: At Enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Hong Qi, Dr.
role: PRINCIPAL_INVESTIGATOR
References: