NCT02309476

Sub-threshold Photocoagulation of Diabetic Macular Oedema

Manchester Pascal Endpoint Management Laser Treatment of Diffuse Diabetic Macular Oedema (DMO): A Safety and Efficacy Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Topcon's Endpoint Management (EM) is a new software from the Pascal® laser which allows us to decrease the intensity of the burns (invisible burns) showing some landmarks with normal intensity so the investigators can see the area which has been treated. The Pascal® system with EM utilizes 577nm laser wavelength compared to the 532nm laser wavelength which was utilized in previous Pascal® laser studies. This study aims to demonstrate that 577nm Pascal® with EM has the same efficacy and effectiveness as 532nm Pascal® in the treatment of diabetic macular oedema.

Detailed description

Diabetic macular oedema (DMO) remains the most common cause of visual loss in diabetic patients and affects around 29% of diabetic patients with 20 or more years of disease. The Early Treatment Diabetic Retinopathy Study (ETDRS) demonstrated a significant benefit of laser photocoagulation for the treatment of clinically significant macular oedema, reducing the incidence of vision loss by approximately 50% at 3 years' follow-up. The original ETDRS photocoagulation technique was adopted throughout the world and gradually modified through the years. Despite the great improvements, loss of central vision, paracentral scotoma and decreased color vision are some adverse events that can still occur, mostly caused by the progressive enlargement of the laser scars consequent to the visible burn of conventional laser photocoagulation. New strategies have been developed for laser treatments that minimize the chorioretinal damage while maintaining at least similar treatment efficacy. And numerous clinical studies have been conducted with subvisible laser treatments. However, the lack of a visible endpoint makes it difficult for the treating physician to know which retinal areas have been treated in order to avoid retreatment and also to be confident that the desired target tissue had been treated. Topcon's Endpoint Management (EM) is a new software from the Pascal® laser which allows us to decrease the intensity of the burns (invisible burns) showing some landmarks with normal intensity so the investigators can see the area which has been treated. The Pascal® system with EM utilizes 577nm laser wavelength compared to the 532nm laser wavelength which was utilized in previous Pascal® laser studies. This study aims to demonstrate that 577nm Pascal® with EM has the same efficacy and effectiveness as 532nm Pascal®.

Conditions

• Diabetic Macular Oedema

Interventions

Type	Name	Description
DEVICE	PASCAL Laser, Green Laser 0.75	Barely Visible Pascal laser grid using 532nm "green" wavelength, 0.75 burn-widths-apart. Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: barely visible burn Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid
DEVICE	PASCAL Laser, Green Laser 1	Barely Visible Pascal laser grid using 532nm "green" wavelength, 1 burn-widths-apart. Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: barely visible burn Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid
DEVICE	PASCAL Laser, 70% Yellow Laser 0.75	Pascal EM at 70% 577nm "yellow" laser grid, 0.75 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: A barely visible burn will be aimed at for the "Landmark" burn and EndPoint Management will be set at 70% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid
DEVICE	PASCAL Laser, 70% Yellow Laser 1	Pascal EM at 70% 577nm "yellow" laser grid, 0.75 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: A barely visible burn will be aimed at for the "Landmark" burn and EndPoint Management will be set at 70% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 1 burn-widths-apart Distribution: Grid
DEVICE	PASCAL Laser, 40% Yellow Laser 0.75	Pascal EM at 40% 577nm "yellow" laser grid, 0.75 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: A barely visible burn will be aimed at for the "Landmark" burn and EndPoint Management will be set at 740% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid
DEVICE	PASCAL Laser, 40% Yellow Laser 1	Pascal EM at 40% 577nm "yellow" laser grid, 0.75 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: A barely visible burn will be aimed at for the "Landmark" burn and EndPoint Management will be set at 740% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2014-12-05
• Last updated: 2020-03-17

Locations

1 site across 1 country: United Kingdom