Diabetic Macular OedemaMEMNCT02309476
Sub-threshold Photocoagulation of Diabetic Macular Oedema
A study testing PASCAL Laser, Green Laser 0.75, PASCAL Laser, Green Laser 1 and PASCAL Laser, 70% Yellow Laser 0.75 in people with Diabetic Macular Oedema, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Oedema
- What is being tested?
- PASCAL Laser, Green Laser 0.75, PASCAL Laser, Green Laser 1 and PASCAL Laser, 70% Yellow Laser 0.75
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient-eligibility
- Older than 18 years of age
- Male or female patients with diabetes mellitus type I or type 2 who meet the WHO or ADA criteria for diabetes
- Able to give informed consent
- Study Eye eligibility
- ETDRS visual acuity equivalent to 35 letters or better (Snellen equivalent 20/200 or better)
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- The patient must have non-proliferative diabetic retinopathy (NPDR) with diffuse macular oedema
- Mean average central retinal thickness at least 300 microns as measured by Deep Range Imaging Optical Coherence Tomography (DRI -OCT) scans
- 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
- Ability to perform accurate Humphmrey visual field test
Who cannot join
- Patient-eligibility
- History of chronic renal failure or renal transplant for diabetic nephropathy
- Recent (last 6 months) or on-going poor glycaemic control. H1Ac greater than 10.0mg/dL
- Creatinine greater than 1.2 mg/dL
- HDL equal to or greater than 40 mg/dL
- Uncontrolled hypertension. Blood pressure greater or equal to 180/110 mmHg
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- Patient is unavailable for follow-up visits
- Pregnant women or breast-feeding females
- Study Eye eligibility
- Lens opacity that could influence vision and results
- Proliferative Diabetic Retinopathy.
- Any surgical or non-retinal laser treatment to the study eye within 2 months
- Narrow drainage angles with raised intraocular pressure and angle closure glaucoma.
- Planned YAG peripheral iridotomy
- Previous retinal laser photocoagulation, intraocular drug therapy, or macular laser treatment to treatment eye in last year
- Vitreomacular traction determined clinically and / or OCT, which in the opinion of the investigator, contributes to macular edema (associated or cause a detachment of the fovea) and prevents the improvement with treatment.
- Atrophy / scar / fibrosis involving the center of the macula, including evidence of atrophy treated with laser within 200 microns of the FAZ.
- Any previous ocular condition that may be associated with a risk of macular edema
- Important known allergies to sodium fluorescein dye used in angiography.
- 12. Active lid or adnexal infection 13. Planned intra-ocular surgery within one year
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Central Manchester Foundation Trust
Manchester, England, M13 9WL
About this study
Official title: Manchester Pascal Endpoint Management Laser Treatment of Diffuse Diabetic Macular Oedema (DMO): A Safety and Efficacy Study
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.
Read the 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
- Being tested
- PASCAL Laser, Green Laser 0.75, PASCAL Laser, Green Laser 1, PASCAL Laser, 70% Yellow Laser 0.75, PASCAL Laser, 70% Yellow Laser 1, PASCAL Laser, 40% Yellow Laser 0.75
- Keywords
- diffuse diabetic macular oedema, Pascal, Laser, DMO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASCAL Laser, Green Laser 0.75Device
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
PASCAL Laser, Green Laser 1Device
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
PASCAL Laser, 70% Yellow Laser 0.75Device
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
PASCAL Laser, 70% Yellow Laser 1Device
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
PASCAL Laser, 40% Yellow Laser 0.75Device
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
PASCAL Laser, 40% Yellow Laser 1Device
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
| Study group | Role | What they receive |
|---|---|---|
| PASCAL Laser, Green Laser 0.75 | Experimental | 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 Receives: Device: PASCAL Laser, Green Laser 0.75 |
| PASCAL Laser, Green Laser 1 burn | Experimental | 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: 1 burn-widths-apart Distribution: Grid Receives: Device: PASCAL Laser, Green Laser 1 |
| PASCAL Laser, 70% Yellow Laser 0.75 | Experimental | 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 Receives: Device: PASCAL Laser, 70% Yellow Laser 0.75 |
| PASCAL Laser, 70% Yellow Laser 1 | Experimental | Pascal EM at 70% 577nm "yellow", 1 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 Receives: Device: PASCAL Laser, 70% Yellow Laser 1 |
| PASCAL Laser, 40% Yellow Laser 0.75 | Experimental | Pascal EM at 40% 577nm "yellow", 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 40% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid Receives: Device: PASCAL Laser, 40% Yellow Laser 0.75 |
| PASCAL Laser, 40% Yellow Laser 1 | Experimental | Pascal EM at 40% 577nm "yellow" laser grid, 1 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 40% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 1 burn-widths-apart Distribution: Grid Receives: Device: PASCAL Laser, 40% Yellow Laser 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of diabetic macular edema (central retinal thickness) within the 6 arms of the study
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
Measured: 12 months
Secondary outcomes (2)
Improvement in visual acuity (> 10 letters or two lines in the ETDRS chart)
Measured: 12 months
increase in retinal sensitivity within the 6 arms of the study
increase in retinal sensitivity will be assessed with fundus-related perimetry (microperimetry)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionDec 2015 (estimated)
Why it stopped: The PI decided to close the study early as patients with diffused macular oedema without any previous treatment are uncommon.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular OedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Topcon Corporation, Optos, PLC
- Responsible party
- Principal investigator, Emma Columbine, Manchester University NHS Foundation Trust
- Investigators
- Paulo Stanga, Principal investigator, Manchester Royal Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309476
- Sponsor's protocol ID
- R03018
- Acronym
- MEM
- Status last verified
- Mar 2020
- First submitted
- 29 Sep 2014
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manchester Pascal Endpoint Management Laser Treatment of Diffuse Diabetic Macular Oedema (DMO): A Safety and Efficacy Study
- ClinicalTrials.gov ID
- NCT02309476
- Acronym / sponsor ID
- MEM / R03018
- Conditions
- Diabetic Macular Oedema
- Keywords
- diffuse diabetic macular oedema, Pascal, Laser, DMO
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI decided to close the study early as patients with diffused macular oedema without any previous treatment are uncommon.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Topcon Corporation, Optos, PLC
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PASCAL Laser, Green Laser 0.75 | Experimental | Device: PASCAL Laser, Green Laser 0.75Barely 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 |
| PASCAL Laser, Green Laser 1 burn | Experimental | Device: PASCAL Laser, Green Laser 1Barely 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: 1 burn-widths-apart Distribution: Grid |
| PASCAL Laser, 70% Yellow Laser 0.75 | Experimental | Device: PASCAL Laser, 70% Yellow Laser 0.75Pascal 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 |
| PASCAL Laser, 70% Yellow Laser 1 | Experimental | Device: PASCAL Laser, 70% Yellow Laser 1Pascal EM at 70% 577nm "yellow", 1 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 |
| PASCAL Laser, 40% Yellow Laser 0.75 | Experimental | Device: PASCAL Laser, 40% Yellow Laser 0.75Pascal EM at 40% 577nm "yellow", 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 40% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid |
| PASCAL Laser, 40% Yellow Laser 1 | Experimental | Device: PASCAL Laser, 40% Yellow Laser 1Pascal EM at 40% 577nm "yellow" laser grid, 1 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 40% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 1 burn-widths-apart Distribution: Grid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient-eligibility
- Older than 18 years of age
- Male or female patients with diabetes mellitus type I or type 2 who meet the WHO or ADA criteria for diabetes
- Able to give informed consent
- Study Eye eligibility
Key exclusion criteria (20 listed)
- Patient-eligibility
- History of chronic renal failure or renal transplant for diabetic nephropathy
- Recent (last 6 months) or on-going poor glycaemic control. H1Ac greater than 10.0mg/dL
- Creatinine greater than 1.2 mg/dL
- HDL equal to or greater than 40 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PASCAL Laser, Green Laser 0.75Barely 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 0.75 |
| PASCAL Laser, Green Laser 1Barely 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, Green Laser 1 burn |
| PASCAL Laser, 70% Yellow Laser 0.75Pascal 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 0.75 |
| PASCAL Laser, 70% Yellow Laser 1Pascal 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, 70% Yellow Laser 1 |
| PASCAL Laser, 40% Yellow Laser 0.75Pascal 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 0.75 |
| PASCAL Laser, 40% Yellow Laser 1Pascal 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 |
Primary outcome
reduction of diabetic macular edema (central retinal thickness) within the 6 arms of the study
Time frame: 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
2 secondary outcomes
Improvement in visual acuity (> 10 letters or two lines in the ETDRS chart)
Time frame: 12 months
increase in retinal sensitivity within the 6 arms of the study
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo Stanga principal investigator
Manchester Royal Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PASCAL Laser, Green Laser 0.75, PASCAL Laser, Green Laser 1 and PASCAL Laser, 70% Yellow Laser 0.75 in people with Diabetic Macular Oedema, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of diabetic macular edema (central retinal thickness) within the 6 arms of the study (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.