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

NCT ID: NCT01928654

Last Updated: 2014-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Micropulse laser treatment

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

Group Type: EXPERIMENTAL

Micropulse laser treatment

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Laser modified ETDRS

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luigi Sacco University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Staurenghi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eye Clinic - Luigi Sacco University Hospital

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Andrea Giani, MD

Role: CONTACT

andrea.giani@unimi.it

+39023904 ext. 2901

Antonio Caimi, MD

Role: CONTACT

antonio.caimi@gmail.com

+39023904 ext. 2441

Facility Contacts

Andrea Giani, MD

Role: primary

andrea.giani@unimi.it

+39023904 ext. 2901

Antonio Caimi, MD

Role: backup

antonio.caimi@gmail.com

+39023904 ext. 2441

Other Identifiers

Lasercomparison

Identifier Type: -

Identifier Source: org_study_id