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Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients. (Pascal)

Primary Purpose

Diabetes Type 1 or 2 With Diabetic Retinopathy

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
PRPC using Pascal laser
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type 1 or 2 With Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diabetes type 1 or 2
  • Subjects with severe non-proliferative or early proliferative diabetic retinopathy (according to the Alfediam classification)
  • Subjects with central macular thickness less than or equal to 350 µm according to spetralis OCT
  • Subjects registered with a social security agency
  • Subjects who have provided written informed consent
  • Subjects aged 18 or above

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding women
  • Patients presenting a contra-indication to Mydriaticum and Neosynephrine
  • History of glaucoma or non-controlled ocular hypertension
  • Blindness in one eye
  • History of renal insufficiency requiring dialysis, or kidney or pancreas transplantation
  • Unbalanced diabetes requiring, in the previous 4 months, intensive insulin therapy.
  • Central macular thickness greater than 350 µm
  • Visual acuity less than 20/32 measured using an ETDRS chart
  • Proliferative diabetic retinopathy associated with "high risk factors" (extensive prepapillary neovessels and/or preretinal or prepapillary neovessels associated with preretinal of intravitreal hemorrhage)
  • Macular edema due to causes other than diabetic retinopathy (venous occlusion, uveitis) or occurring in a context of vitreomacular traction
  • Already started PRPC
  • History of eye surgery or YAG laser capsulotomy performed during the preceding 6 months
  • Subjects under legal supervision or guardianship

Sites / Locations

  • CHU Dijon
  • CHU de la Croix Rousse
  • Hôpital Lariboisière

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

A session

Four sessions

Arm Description

Every session are spaced out of month

Outcomes

Primary Outcome Measures

Macular thickness
Central macular thickness at 9 months after the start of PRPC using Pascal laser.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2013
Last Updated
December 26, 2018
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT01766362
Brief Title
Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.
Acronym
Pascal
Official Title
Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and doctor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 1 or 2 With Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A session
Arm Type
Experimental
Arm Title
Four sessions
Arm Type
Other
Arm Description
Every session are spaced out of month
Intervention Type
Procedure
Intervention Name(s)
PRPC using Pascal laser
Primary Outcome Measure Information:
Title
Macular thickness
Description
Central macular thickness at 9 months after the start of PRPC using Pascal laser.
Time Frame
9 months after the start of traitement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes type 1 or 2 Subjects with severe non-proliferative or early proliferative diabetic retinopathy (according to the Alfediam classification) Subjects with central macular thickness less than or equal to 350 µm according to spetralis OCT Subjects registered with a social security agency Subjects who have provided written informed consent Subjects aged 18 or above Exclusion Criteria: Pregnancy Breastfeeding women Patients presenting a contra-indication to Mydriaticum and Neosynephrine History of glaucoma or non-controlled ocular hypertension Blindness in one eye History of renal insufficiency requiring dialysis, or kidney or pancreas transplantation Unbalanced diabetes requiring, in the previous 4 months, intensive insulin therapy. Central macular thickness greater than 350 µm Visual acuity less than 20/32 measured using an ETDRS chart Proliferative diabetic retinopathy associated with "high risk factors" (extensive prepapillary neovessels and/or preretinal or prepapillary neovessels associated with preretinal of intravitreal hemorrhage) Macular edema due to causes other than diabetic retinopathy (venous occlusion, uveitis) or occurring in a context of vitreomacular traction Already started PRPC History of eye surgery or YAG laser capsulotomy performed during the preceding 6 months Subjects under legal supervision or guardianship
Facility Information:
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75475
Country
France

12. IPD Sharing Statement

Learn more about this trial

Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.

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