Single-session panretinal PRP (SS-PRP): Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas in one comprehensive session, typically delivered in a single clinical visit.
Multiple-session panretinal PRP (MS-PRP): Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas over two separate visits with at least one week apart.
Study summary
Proliferative diabetic retinopathy (PDR) is the leading cause for blindness in working-age adults. The current gold standard treatment for PDR is panretinal photocoagulation (PRP). In current clinical practice, both single-session and multiple-session PRP approaches are widely accepted and utilized. The purpose of this study is to compare the safety and effectiveness of single-session and multiple-session PRP.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age \> 18 years.
* Patients with type 1 or type 2 Diabetes Mellitus with newly diagnosed Proliferative Diabetic Retinopathy, PDR.
* Visual acuity ≥ 0.1 Snellen.
* CRT of less than 300 micrometer measured by OCT without cysts in the neuroretina.
* Clear media and adequately dilated pupil for PRP.
Exclusion Criteria:
* Intraocular surgery within the last 4 months or planned within the next 3 months.
* Previous or current center-involved diabetic macular edema (Ci-DME).
* Previous PRP, intravitreal treatment (IVT), or macular laser treatment in study eye.
* Treatment with medications known to risk macular edema.
* Media opacity preventing adequate PRP.
* General medical condition making office laser treatment very difficult or impossible.
Primary outcome measure(s)
Central subfield retinal thickness (CRT) — Baseline and 1, 3 and 6 months after treatment Mean change from baseline in CRT
Vessel Perfusion Density (VPD) — Baseline and 1, 3 and 6 months after treatment Mean change from baseline in VPD
Vessel Length Density (VLD) — Baseline and 1, 3 and 6 months after treatment Mean change from baseline in VLD
Foveal Avascular Zone (FAZ) — Baseline and 1, 3 and 6 months after treatment Mean change from baseline in FAZ
Lesion size — Baseline and 1, 3 and 6 months after treatment Mean change from baseline in lesion size
Macular volume — Baseline and 1, 3 and 6 months after treatment Mean change from baseline in macular volume
Venular saturation — Baseline and 1, 3 and 6 months after treatment Mean change from baseline in venular saturation
Arteriolar saturation — Baseline and 1, 3 and 6 months after treatment Mean change from baseline in arteriolar saturation
Retinal diameter — Baseline and 1, 3 and 6 months after treatment Mean change from baseline in retinal diameter
Venular diameter — Baseline and 1, 3 and 6 months after treatment Mean change from baseline in venular diameter
Retinal function — Baseline and 1, 3 and 6 months after treatment Mean change from baseline in retinal function using full-field electroretinogram (ERG)
Diabetic macular edema (DME) — Baseline and 1, 3 and 6 months after treatment Incidence of diabetic macular edema (DME)
Subjective experience of pain after treatment — Baseline and 1, 3 and 6 months after treatment Study patients' subjective experience of pain after treatment using visual analog scale (VAS)
Subjective overall experience of the treatment — Baseline and 1, 3 and 6 months after treatment Study patients' subjective overall experience of the treatment using verbal scale (VS)
Cost-effectiveness — Baseline and 1, 3 and 6 months after treatment We intend to conduct a thorough cost-effectiveness analysis, comparing the single-session approach with the traditional multiple-session treatments.
This analysis will factor in direct medical costs, including the expenses related to the laser equipment, healthcare professionals' time, and the required clinical facilities. We will also consider indirect costs such as patient travel expenses and time taken off work.
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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