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

NCT01928654 | Unknown

• 1 other identifier: Lasercomparison
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

Edema; Diabetic; Laser; Treatment

Outcome Measures

Primary Outcomes (1)

• Mean change in visual acuity (ETDRS letters)

  12 months

Secondary Outcomes (3)

• Mean change in central retinal thickness

  12 months

• Percentage of patients gaining ETDRS lines

  12 months

• Percentage of patients losing ETDRS lines

  12 months

Study Arms (2)

Micropulse laser treatment

EXPERIMENTAL

Sub-threshold laser treatment covering the area of retinal thickening with a dense pattern

Device: Micropulse laser treatment

Laser modified ETDRS

ACTIVE COMPARATOR

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

Interventions

Micropulse laser treatment DEVICE

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.

Micropulse laser treatment

Laser modified ETDRS DEVICE

Device for visible treatment of the retina, with direct treatment of microaneurysms or grid pattern covering the area of retinal edema.

Laser modified ETDRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Luigi Sacco University Hospital: lead

Study Sites (1)

Eye Clinic - Luigi Sacco University Hospital

Milan, 20157, Italy

RECRUITING

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrea Giani, MD

CONTACT

+39023904; andrea.giani@unimi.it

Antonio Caimi, MD

CONTACT

+39023904; antonio.caimi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 27, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 19, 2014

Record last verified: 2014-03

Locations

IT (1)