Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549023
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single Session vs Multiple-Session Panretinal Photocoagulation With Navigated Laser in Proliferative Diabetic Retinopathy - The SMART-PRP Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART-PRP
Brief 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
Detailed Description:
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 practitioners preference patient characteristics and specific clinical circumstances
Although both single-session and multiple-session PRP are employed in practice theres 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
Although both single-session and multiple-session PRP are employed in practice theres 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None