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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01928654
• Other study ID #: Lasercomparison
• Status: Recruiting
• Phase: N/A
• First received: August 21, 2013
• Last updated: March 18, 2014
• Start date: July 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2014
• Source: Luigi Sacco University Hospital
• Contact: Andrea Giani, MD
• Phone: +39023904
• Email: andrea.giani[@]unimi.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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

Locations

Country	Name	City	State
Italy	Eye Clinic - Luigi Sacco University Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Luigi Sacco University Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in visual acuity (ETDRS letters)		12 months	No
Secondary	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	No
Secondary	Percentage of patients gaining ETDRS lines	Percentage of patients that gain 1, 2, or 3 ETDRS lines of visual acuity	12 months	No
Secondary	Percentage of patients losing ETDRS lines	PErcentage of patients that loose 1, 2, or 3 ETDRS lines of visual acuity	12 months	No