Investigating the Retardation Effect of OCTA-Guided Targeted Photocoagulation on the Progression … (NCT06821633) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Investigating the Retardation Effect of OCTA-Guided Targeted Photocoagulation on the Progression of Non-Perfusion Areas in Diabetic Retinopathy Patients
China30 participantsStarted 2025-07-07
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The area size of NP (in PD units) in two groups of eyes at 0, 3, 6, 9, and 12 months
Timeframe: From enrollment to reexamination at 0,3,6,9, and 12 months