Proliferative Diabetic RetinopathyPhotocoagulation Burn to Retina
Investigational drug(s) / intervention(s)
A new pattern of retinal laser
A new pattern of retinal laser: A new pattern of retinal argon laser combines anti VEGF treatment within 2 weeks. Spot argon-laser photocoagulation was started 1 disc-diameter nasal to the optic disc, outside the superior and inferior vascular arcades, and 2 disc diameter (DD) temporal to the fovea, and the mid-peripheral retina flanking the large vessels. Further peripheral PRP and anti-VEGF administration would be added only if neovascularization progress.
Study summary
The objective of the study is to evaluate the efficacy of a new pattern of argon-laser in treating patients with proliferative diabetic retinopathy (PDR).
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Having given free and informed consent to take part in the study.
2. Diabetes mellitus (DM) under stable treatment during the study, aged 18y to 70y, with no significant underlying systemic diseases (such as impaired renal function, severe cardiac disease, etc.);
3. Clinically diagnosed PDR, with the presence of neovascularization confirmed by ultra-widefield fundus photography and widefield OCT angiography.
Exclusion Criteria:
1. Previous treatment with PRP;
2. Previous treatment with anti-VEGF agents or corticosteroids within 3 months;
2\. Severe cataract, massive vitreous hemorrhage, or extensive preretinal hemorrhage that makes pan retinal photocoagulation impossible; 3. Unable to tolerate argon-laser retinal treatment.; 4. Vitreous macular traction or traction retinal detachment need to be performed with vitrectomy; 5. Retinal vascular occlusion, age-related macular degeneration, retinal angioma, uveitis, glaucoma, optic neuropathy, or other ocular diseases that can lead to vitreous hemorrhage and/or neovascularization; 6. Other conditions that the researcher found improper to be included into this study.
Primary outcome measure(s)
BCVA — From enrollment to the end of the 2-year follow-up period. (at enrollment; 1 month, 3months, 6 months, 1 year and 2 years after the initial laser treatment) BCVA stands for best-corrected visual acuity, measured by Snellen chart.
CMT — From enrollment to the end of the 2-year follow-up period. (at enrollment; 1 month, 3months, 6 months, 1 year and 2 years after the initial laser treatment) CMT stands for central macular thickness, measured with optical coherence tomography (OCT) images, which serves as one of the key indicators of DR progression.
Mean VF loss — 1 year and 2 years after the initial laser treatment during the follow-up period. VF stands for visual field. Mean deviation would be used to evaluate the VF loss.
Further treatment — From enrollment to the end of the 2-year follow-up period. Number of participants with further laser treatment, anti-VEGF treatment or vitrectomy.
Trial sites (1)
Facility
City
Region
Status
Eye and ENT Hospital of Fudan University
Shanghai
Shanghai Municipality
More Eye & ENT Hospital of Fudan University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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