NCT06821633Not yet recruiting
Investigating the Retardation Effect of OCTA-Guided Targeted Photocoagulation on the Progression of Non-Perfusion Areas in Diabetic Retinopathy Patients
Source: ClinicalTrials.gov · Last updated 21 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 6 Feb 2025
- Start date
- 7 Jul 2025
- Primary completion date
- 7 Aug 2026
- Lead sponsor
- Sichuan Provincial People's Hospital
- Diseases
- Diabetic eye disease
- NCT number
- NCT06821633
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 7 Jul 2025 to the primary completion date, 7 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with renal failure, diabetic neuropathy, or severe cardiovascular diseases
- 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)
Other
- Optical media opacity affecting OCTA imaging
- Patients with difficulties in cooperating with laser treatment
- Patients who are unlikely to complete follow-ups every 3 months, as well as those residing in other provinces
- 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%
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.