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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Device: Micropulse laser treatment; Device: Laser modified ETDRS

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Giani, MD; Phone Number: 2901 +39023904; Email: andrea.giani@unimi.it
• Study Contact Backup: Name: Antonio Caimi, MD; Phone Number: 2441 +39023904; Email: antonio.caimi@gmail.com

Study Locations

• Italy
  • Milan, Italy, 20157
    • Recruiting
    • Eye Clinic - Luigi Sacco University Hospital
    • Contact: Andrea Giani, MD; Phone Number: 2901 +39023904; Email: andrea.giani@unimi.it
    • Contact: Antonio Caimi, MD; Phone Number: 2441 +39023904; Email: antonio.caimi@gmail.com
    • Sub-Investigator: Andrea Giani, MD
    • Principal Investigator: Giovanni Staurenghi, MD
    • Sub-Investigator: Luigi Bonavia, MD
    • Sub-Investigator: Antonio Caimi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Micropulse laser treatment; Sub-threshold laser treatment covering the area of retinal thickening with a dense pattern	Device: Micropulse laser treatment; 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.
Active Comparator: Laser modified ETDRS; 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; Device for visible treatment of the retina, with direct treatment of microaneurysms or grid pattern covering the area of retinal edema.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Luigi Sacco University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): November 1, 2014

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: August 21, 2013
• First Posted (Estimate): August 27, 2013

Study Record Updates

• Last Update Posted (Estimate): March 19, 2014
• Last Update Submitted That Met QC Criteria: March 18, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Treatment; Diabetic; Edema; Laser
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: Lasercomparison