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

NCT06727955 | Not Yet Recruiting

• 1 other identifier: M2023514
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Keywords

diabetic retinopathy; artificial intelligence model; multimodal eye imaging

Outcome Measures

Primary Outcomes (1)

• DRSS Score and Classification

  The progression of DR is based on the increase of DRSS score and classification. Ophthalmologists at the Department of Ophthalmology, Peking University Third Hospital, will independently read UWF CFP in a semi-quantitative manner to assess the severity of DR based on the DRSS. Progression of DR in T2DM patients with varying degrees of NPDR is calculated based on DRSS. An increase of at least one level in grading is considered progression. For instance, progression from grade 43A to 47A or higher is considered progression, while progression from 43A to 43B is not.

  At Enrollment

Secondary Outcomes (2)

• Renal Function Test

  At Enrollment

• Peripheral Neuropathy Assessment

  At Enrollment

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Hong Qi, Dr.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Qi, Dr.

CONTACT

+8613901066889; doctorqihong@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 11, 2024

Record last verified: 2024-11

Locations

CN (1)