Investigating the Retardation Effect of OCTA-Guided Targeted Photocoagulation on the Progression of Non-Perfusion Areas in Diabetic Retinopathy Patients

Launched by SICHUAN PROVINCIAL PEOPLE'S HOSPITAL · Feb 11, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with diabetic retinopathy, a condition that can affect vision in people with diabetes. The researchers want to find out if using a special imaging technique called OCTA to guide laser treatment can help slow down the progression of areas in the retina that are not getting enough blood flow (known as non-perfusion areas). They will compare two groups of patients: one group will receive the laser treatment aimed at these areas, while the other group will not receive any treatment. The study will track changes in these areas and overall diabetic retinopathy severity over a year.

To participate in this study, candidates must be at least 18 years old and have either type 1 or type 2 diabetes with specific signs of diabetic retinopathy that are not too advanced. Eligible participants will have both eyes affected but at the same stage of the disease, allowing for a fair comparison. Those who join can expect to attend follow-up visits every three months for a year to monitor their condition. It’s important to note that certain health issues or recent treatments may disqualify some patients from participating, so a thorough screening will be done to ensure safety and suitability for the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • 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:
• • Optical media opacity affecting OCTA imaging
• • 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%