Diabetes Type 1 or 2 With Diabetic Retinopathy Clinical Trial
— PascalOfficial title:
Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.
| Verified date | December 2018 |
| Source | Centre Hospitalier Universitaire Dijon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 83 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Dijon | Dijon | |
| France | CHU de la Croix Rousse | Lyon | |
| France | Hôpital Lariboisière | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Macular thickness | Central macular thickness at 9 months after the start of PRPC using Pascal laser. | 9 months after the start of traitement |