Diabetic Macular Oedema
Conditions
Keywords
diffuse diabetic macular oedema, Pascal, Laser, DMO
Brief 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®.
Interventions
DEVICEPASCAL 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
DEVICEPASCAL 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
DEVICEPASCAL 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
DEVICEPASCAL 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
DEVICEPASCAL 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
DEVICEPASCAL 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
Sponsors
Topcon Corporation
Optos, PLC
Manchester University NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient-eligibility Inclusion criteria: 1. Older than 18 years of age 2. Male or female patients with diabetes mellitus type I or type 2 who meet the WHO or ADA criteria for diabetes 3. Able to give informed consent Study Eye eligibility Inclusion criteria: 1. ETDRS visual acuity equivalent to 35 letters or better (Snellen equivalent 20/200 or better) 2. The patient must have non-proliferative diabetic retinopathy (NPDR) with diffuse macular oedema 3. Mean average central retinal thickness at least 300 microns as measured by Deep Range Imaging Optical Coherence Tomography (DRI -OCT) scans 4. Adequate pupil dilatation and clear media to perform wide-field colour, red-free imaging and fundus fluorescein angiography (WF-FFA), wide-field fundus autofluorescence imaging (WF-AF) and DRI-OCT 5. Ability to perform accurate Humphmrey visual field test
Exclusion criteria
Patient-eligibility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction of diabetic macular edema (central retinal thickness) within the 6 arms of the study | 12 months | To compare Green Pascal® laser and Yellow Pascal® laser using EM among 6 groups of participants using Pascal® laser with an application of full grid 112 burns in a single session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in visual acuity (> 10 letters or two lines in the ETDRS chart) | 12 months | — |
| increase in retinal sensitivity within the 6 arms of the study | 12 months | increase in retinal sensitivity will be assessed with fundus-related perimetry (microperimetry) |
Countries
United Kingdom
Outcome results
None listed