NCT02309476

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

September 29, 2014

Last Update Submit

March 16, 2020

Conditions

Diabetic Macular Oedema

Keywords

diffuse diabetic macular oedemaPascalLaserDMO

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (2)

  • 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

Study Arms (6)

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

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

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

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

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

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

Device: PASCAL Laser, 40% Yellow Laser 1

Interventions

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 0.75
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, Green Laser 1 burn
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 0.75
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, 70% Yellow Laser 1
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 0.75
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

PASCAL Laser, 40% Yellow Laser 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Manchester Foundation Trust

Manchester, England, M13 9WL, United Kingdom

Location

Study Officials

  • Paulo Stanga

    Manchester Royal Eye Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Paulo Stanga

Study Record Dates

First Submitted

September 29, 2014

First Posted

December 5, 2014

Study Start

October 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations

GB(1)