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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography Angiography)

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Eyes with NPDR that were diagnosed and underwent TRP guided by OCTA at our hospitalExperimental treatment 1 intervention
Group B: Eyes with NPDR that were diagnosed at our hospitalNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The area size of NP (in PD units) in two groups of eyes at 0, 3, 6, 9, and 12 months

Time frame
From enrollment to reexamination at 0,3,6,9, and 12 months

Secondary outcomes

1

The number of microaneurysms, intraretinal microvascular abnormalities (IRMA) in both groups of eyes at 0, 3, 6, 9, and 12 months

Time frame
From enrollment to reexamination at 0,3,6,9, and 12 months
2

The number of neovascularization (NV) in both groups of eyes at 0, 3, 6, 9, and 12 months

Time frame
From enrollment to reexamination at 0,3,6,9, and 12 months
3

Area of foveal avascular zone (FAZ) at 0, 3, 6, 9, and 12 months in two groups of eyes

Time frame
From enrollment to reexamination at 0,3,6,9, and 12 months
4

DR grading at 0, 3, 6, 9, and 12 months in two groups of eyes

Time frame
From enrollment to reexamination at 0,3,6,9, and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: