Investigating the Retardation Effect of OCTA-Guided Targeted Photocoagulation on the Progression of Non-Perfusion Areas in Diabetic Retinopathy Patients
NCT ID: NCT06821633
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-07-07
2026-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Eyes with NPDR that were diagnosed and underwent TRP guided by OCTA at our hospital
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.
Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography Angiography)
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.
Eyes with NPDR that were diagnosed at our hospital
Perform the same examination but administer no treatment
No interventions assigned to this group
Interventions
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Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography Angiography)
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.
Eligibility Criteria
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Inclusion Criteria
* Type 1 or Type 2 diabetes mellitus
* Clinical dilated fundus examination and Optos imaging within 7 fields showing diabetic retinopathy (DR) lesions no more severe than severe non-proliferative diabetic retinopathy (NPDR)
* Optical coherence tomography angiography (OCTA) demonstrating non-perfusion (NP) areas greater than 1 disc diameter (PD) in both eyes
* Diabetic retinopathy in both eyes at the same stage, with the total NP area within the observed range of OCTA being comparable (difference less than 5 PD)
* Absence of other ocular diseases that could lead to the formation of retinal microaneurysms
* Absence of other ocular diseases that could lead to the formation of retinal non-perfusion areas
* No diabetic macular edema involving the fovea
* No history of retinal laser treatment
* No history of intravitreal injection therapy within the past 3 months
* No history of ocular surgery other than cataract surgery
* Ability to cooperate with all examinations and provide informed consent
Exclusion Criteria
* Patients with difficulties in cooperating with laser treatment
* Patients with renal failure, diabetic neuropathy, or severe cardiovascular diseases
* Patients who are unlikely to complete follow-ups every 3 months, as well as those residing in other provinces
* Patients requiring early PRP (conditions include: combined DME, planned cataract surgery, pregnancy planning, early PDR, poor follow-up compliance, severe vision loss in the other eye, poor glycemic control, poor renal function, or type 1 diabetes)
* FFA showing NP greater than 10 PD within the ETDRS area or a total NP area greater than 75 PD, or an ischemia index greater than 35%
18 Years
ALL
No
Sponsors
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Sichuan Provincial People's Hospital
OTHER
Responsible Party
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Jie Li
Principal Investigator
Locations
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Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-KY740-1
Identifier Type: -
Identifier Source: org_study_id
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