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Panretinal Photo-stimulation in Proliferative Diabetic Retinopathy

NCT02309502 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-03-17

No results posted yet for this study

Summary

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.

Conditions

  • Severe Non-proliferative Diabetic Retinopathy

Interventions

DEVICE

Green Pascal

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

DEVICE

Yellow Pascal

: 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

Sponsors & Collaborators

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Paulo Stanga · Manchester Royal Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02309502 on ClinicalTrials.gov