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This study aims to evaluate the impact of widefield OCTA-guided selective photocoagulation on the progression of diabetic retinopathy (DR) by comparing the control of non-perfusion (NP) areas, DR grading, and management of other DR lesions. The study is designed as a parallel randomized controlled trial. From February 2025 to August 2026, 30 diabetic patients attending the Ophthalmology Department of Sichuan Provincial People's Hospital will be enrolled. Using a simple randomization method, one eye of each patient will be assigned to the intervention group, while the contralateral eye will serve as the control, resulting in 30 eyes in each group. The intervention group will undergo OCTA-guided selective photocoagulation, specifically using a grid pattern (3x3) of spot laser applied once to the NP area, extending one spot diameter beyond the NP boundary. Each session will last 10-20 minutes. The control group will receive no treatment. The study will compare changes in NP area, DR grading progression, and control of other DR lesions at 3, 6, 9, and 12 months between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eyes with NPDR that were diagnosed and underwent TRP guided by OCTA at our hospital | Experimental | The patient's eyes were first scanned using the Topcon OCTA (five-field montage) with a 24×20mm and a 6×6mm scan range. After enrollment, the patient underwent treatment on the same day in the retinal laser room. The laser treatment was performed by the same ophthalmologist. After obtaining baseline fundus images, the treating ophthalmologist overlaid the OCTA images onto the fundus images using retinal vessel alignment to guide targeted photocoagulation of the retinal non-perfusion (NP) areas under OCTA guidance. The specific photocoagulation method involved applying a grid pattern of spot laser (3×3) to the NP area once, with the treatment area extending beyond the NP boundary by one laser spot diameter. The total procedure duration was 10-20 minutes. |
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| Eyes with NPDR that were diagnosed at our hospital | No Intervention | Perform the same examination but administer no treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography Angiography) | Procedure | The patient's eyes were first scanned using the Topcon OCTA (five-field montage) with a 24×20mm and a 6×6mm scan range. After enrollment, the patient underwent treatment on the same day in the retinal laser room. The laser treatment was performed by the same ophthalmologist. After obtaining baseline fundus images, the treating ophthalmologist overlaid the OCTA images onto the fundus images using retinal vessel alignment to guide targeted photocoagulation of the retinal non-perfusion (NP) areas under OCTA guidance. The specific photocoagulation method involved applying a grid pattern of spot laser (3×3) to the NP area once, with the treatment area extending beyond the NP boundary by one laser spot diameter. The total procedure duration was 10-20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| The area size of NP (in PD units) in two groups of eyes at 0, 3, 6, 9, and 12 months | From enrollment to reexamination at 0,3,6,9, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The number of microaneurysms, intraretinal microvascular abnormalities (IRMA) in both groups of eyes at 0, 3, 6, 9, and 12 months | From enrollment to reexamination at 0,3,6,9, and 12 months | |
| The number of neovascularization (NV) in both groups of eyes at 0, 3, 6, 9, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Li, doctor | Contact | +86 139 0809 4675 | lijieyk@med.uestc.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610014 | China |
2030, via https://pan.baidu.com
2025 and forever
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| From enrollment to reexamination at 0,3,6,9, and 12 months |
| Area of foveal avascular zone (FAZ) at 0, 3, 6, 9, and 12 months in two groups of eyes | From enrollment to reexamination at 0,3,6,9, and 12 months |
| DR grading at 0, 3, 6, 9, and 12 months in two groups of eyes | From enrollment to reexamination at 0,3,6,9, and 12 months |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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