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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01766362

Acronym

Pascal

Enrollment

Registered

2013-01-11

Start date

2011-10-01

Completion date

2015-11-01

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 1 or 2 With Diabetic Retinopathy

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.

Interventions

PROCEDUREPRPC using Pascal laser

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Macular thickness	9 months after the start of traitement	Central macular thickness at 9 months after the start of PRPC using Pascal laser.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026