Comparison Between Treatment With Yellow Micropulse Laser and Green Conventional Laser in Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
Macular edema is the most important cause of visual impairment in diabetic patients. Intravitreal injections of antiVEGF (vascular endothelial growth factor) agents and laser treatment are two effective therapies for stabilising visual acuity. However, antiVEGF therapy is very expensive and potentially needs to to be repeated for all patients life. Laser treatment, according to modified ETDRS (early treatment diabetic retinopathy study), produces retinal burns with possible negative consequences such as alterations in the visual fields. With micropulse treatment modality laser energy is delivered in short pulses (micropulses) rather than as a continuous wave. In this way the amount of energy delivered to the retina and retinal pigment epithelium (RPE) is significantly reduced. This finer control of the photothermal effects should avoid any retinal and RPE damage. At the same time, according to several published reports, the efficacy of treatment appears to be equivalent to conventional laser therapy. Previous studies investigated the effects of 810nm micropulse laser therapy. Recently, this treatment modality has been made available also with 577nm wavelength, which corresponds to the maximum absorption level for blood. Aim of this study is to assess the safety and efficacy of 577nm micropulse laser treatment compared to conventional modified ETDRS laser therapy.

Official Title
-----------------
Comparison Between Treatment With Yellow Micropulse Laser and Green Conventional Laser in Diabetic Macular Edema

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Device: Micropulse laser treatment
* Device: Laser modified ETDRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent prior to study entry male or female patients >= 18 years of age patients with diagnosis of diabetes type 1 or 2 and clinically significant macular edema visual impairment due to clinically significant diabetic macular edema best-corrected visual acuity included between 21 and 74 ETDRS letters central retinal thickness greater than 320 micron (Spectralis SD-OCT, Heidelberg Engineering, Germany) leakage and/or micro aneurysm in fluorescein angiography images within the area of retinal thickening HbA1C ≤10% with well-controlled blood pressure and renal function Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micropulse laser treatment<br>Sub-threshold laser treatment covering the area of retinal thickening with a dense pattern | Device: Micropulse laser treatment<br>* Device for subthreshold treatment of the retina, by decomposing a continuos wave of laser in micropulses, with 5% duty cycle, 200 milliseconds, 100 microns, and power adjusted according to patient's diopter transparency and pigmentation.<br>|
| Active Comparator: Laser modified ETDRS<br>Macular treatment using the modified ETDRS protocol, with barely visible laser burns to close microaneurysms, or with a grid pattern in the area of retinal thickening. | Device: Laser modified ETDRS<br>* Device for visible treatment of the retina, with direct treatment of microaneurysms or grid pattern covering the area of retinal edema.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in visual acuity (ETDRS letters) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in central retinal thickness | Central retinal thickness corresponds to the mean retinal thickness within the 1-mm central subfield centred on the fovea. This measurement is obtained with Spectralis spectral-domain optical coherence tomography (SD-OCT) (Heidelberg Engineering, Germany). | 12 months | 
| Percentage of patients gaining ETDRS lines | Percentage of patients that gain 1, 2, or 3 ETDRS lines of visual acuity | 12 months | 
| Percentage of patients losing ETDRS lines | PErcentage of patients that loose 1, 2, or 3 ETDRS lines of visual acuity | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Edema, Diabetic, Laser, Treatment