NCT02309502|Withdrawn
Panretinal Photo-stimulation in Proliferative Diabetic Retinopathy
PRPhS
Pascal Pan Retinal Photo-Stimulation in Pre-Proliferative Diabetic Retinopathy: a Safety and Efficacy Study
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PRPhS
Pascal Pan Retinal Photo-Stimulation in Pre-Proliferative Diabetic Retinopathy: a Safety and Efficacy Study
Sponsor study identifier
interventional
0
1 country
1
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Diabetic retinopathy (DR) is a leading cause of new cases of blindness in people aged 20 to 65 years worldwide. Patients with DR may go on to develop a more severe form of the disease called Proliferative Diabetic Retinopathy (PDR), a condition in which abnormal new blood vessels may rupture and bleed inside the eye. When this advanced stage of retinopathy occurs, pan-retinal photocoagulation (laser treatment) is usually recommended. The purpose of the investigators study is to find if treating patients using a single session of lower intensity laser (Pascal® Pan Retinal Photo-Stimulation, P-RPhS) at an earlier stage in Diabetic Retinopathy (during the severe non-proliferative diabetic retinopathy stage) when the abnormal new vessels are not developed, will prevent diabetic patients to develop PDR. Patients included in the study will be randomized in three arms (randomization). In one arm patients will be treated with the normal parameters used in Pascal® laser, the second arm patients will be treated with a lower intensity than normal, using the Endpoint management system (a new software from the Pascal® laser which allow us to decrees the intensity of the burns (invisible burns) showing some landmarks with normal intensity so the area which has been treated can be viewed. And in the third arm the patients will be observed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
September 29, 2014
Actual (reported)December 2014
Actual (reported)December 5, 2014
Actual (reported)December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
prevention on the developing of proliferative diabetic retinopathy (assessed with slitlamp, color fundus, and fluorangiography)
assessed with slitlamp, color fundus, and fluorangiography
12 months
regression of Diabetic Retinopathy from Severe Non-Proliferative Stage (S-NPDR) to Moderate Non-Proliferative Stage (M-NPDR) or lesser severity of retinopathy
12 months
reduction in visual acuity
12 months
reduction in the field of vision
12 months
reduction of central retinal thickness
12 months
Pain assessment (questionnaire)
12 months
Single-session Barely Visible Pascal 532nm 3,000 burns 20ms
Single-session P-RPhS; Pascal 577nm 3000 burns 20ms Endpoint Management:70%
Observation
Single-session Barely Visible Pascal 532nm 3,000 burns 20ms Multi-spot, single session Number of burns: 3,000 Spot size: 400micron Duration: 0.02seconds Exposure: 100% Average power: 100 to 1000 mW Spot spacing: 1 burn-width apart Total number of burns: 3,000 Distribution: From the vascular arcades towards the periphery and in the four quadrants
: Single-session P-RPhS; Pascal 577nm 3000 burns 20ms Endpoint Management: 70% Number of burns: 3,000 Spot size: 400micron Duration: 0.02seconds Exposure: A barely visible burn will be aimed at for the pattern "landmark" burns and EndPoint Management will be set at 70% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 1 burn-width apart Total number of burns: 3,000 Distribution: From the vascular arcades towards the periphery and in the four quadrants
Central Manchester Foundation Trust
Manchester, England, M13 9WL, United Kingdom
Paulo Stanga
Manchester Royal Eye Hospital
0 participants (actual enrollment reported by the registry).
First Submitted
September 29, 2014
First Posted
December 5, 2014
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 17, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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