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

Not Applicable

• Conditions: Diabetic Macular Edema
• Interventions: Device: Laser modified ETDRS; Device: Micropulse laser treatment

• Registration Number: NCT01928654
• Lead Sponsor: Luigi Sacco University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-21
• Study First Posted: 2013-08-27
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-18
• Last Update Posted: 2014-03-19
• Primary Completion: 2014-10
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser modified ETDRS	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.
Micropulse laser treatment	Micropulse laser treatment	Sub-threshold laser treatment covering the area of retinal thickening with a dense pattern

Primary Outcome Measures

Name	Time	Method
Mean change in visual acuity (ETDRS letters)	12 months

Secondary Outcome Measures

Name	Time	Method
Mean change in central retinal thickness	12 months	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).
Percentage of patients gaining ETDRS lines	12 months	Percentage of patients that gain 1, 2, or 3 ETDRS lines of visual acuity
Percentage of patients losing ETDRS lines	12 months	PErcentage of patients that loose 1, 2, or 3 ETDRS lines of visual acuity

Trial Locations

Locations (1)

Eye Clinic - Luigi Sacco University Hospital; 🇮🇹 Milan, Italy