Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy

Официальное название

Single Session vs Multiple-Session Panretinal Photocoagulation With Navigated Laser in Proliferative Diabetic Retinopathy - The SMART-PRP Study

Обзор

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.

Подробное описание

Proliferative diabetic retinopathy (PDR) is a well-known complication for both type 1 and type 2 diabetes mellitus (DM) and it is the leading cause for blindness in working-age adults. The current gold standard treatment for PDR, established more than four decades ago by the Diabetic Retinopathy Study (DRS), is panretinal photocoagulation (PRP). The treatment goal is to halt the progression of PDR by destroying parts of the peripheral retina in a pattern fashion and hence preserving the visually important central macular region. The tissue destruction reduces the area of ischemia and reduces the production of vascular endothelial growth factor (VEGF), which drives the formation of neovascular proliferations. In the management of PDR, panretinal photocoagulation (PRP) stands as a cornerstone treatment. In current clinical practice, both single-session and multiple-session PRP approaches are widely accepted and utilized. The choice between these approaches often depends on the practitioner's preference, patient characteristics, and specific clinical circumstances.

Although both single-session and multiple-session PRP are employed in practice, there's an ongoing debate regarding their comparative safety and effectiveness. Older studies suggest a heightened risk of diabetic macular edema (DME) with single-session PRP, while newer research, particularly those involving milder laser techniques, indicates that the risk might be similar regardless of the number of sessions. This inconsistency in findings underscores the need for further research and the investigators aim to shed light over this with this prospective, controlled and randomized interventional study.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Central subfield retinal thickness (CRT) [Срок оценки: Baseline and 1, 3 and 6 months after treatment]
• Vessel Perfusion Density (VPD) [Срок оценки: Baseline and 1, 3 and 6 months after treatment]
• Vessel Length Density (VLD) [Срок оценки: Baseline and 1, 3 and 6 months after treatment]
• Foveal Avascular Zone (FAZ) [Срок оценки: Baseline and 1, 3 and 6 months after treatment]
• Lesion size [Срок оценки: Baseline and 1, 3 and 6 months after treatment]
• Macular volume [Срок оценки: Baseline and 1, 3 and 6 months after treatment]
• Venular saturation [Срок оценки: Baseline and 1, 3 and 6 months after treatment]
• Arteriolar saturation [Срок оценки: Baseline and 1, 3 and 6 months after treatment]
• Retinal diameter [Срок оценки: Baseline and 1, 3 and 6 months after treatment]
• Venular diameter [Срок оценки: Baseline and 1, 3 and 6 months after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Ögonmottagning Mölndal/SU — Mölndal

Идентификаторы

NCT: NCT06549023 · SMART-PRP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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