Comparison Between Treatment With Yellow Micropulse Laser and Green Conventional Laser in Diabetic Macular Edema
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|ClinicalTrials.gov Identifier: NCT01928654|
Recruitment Status : Unknown
Verified March 2014 by Giovanni Staurenghi, Luigi Sacco University Hospital.
Recruitment status was: Recruiting
First Posted : August 27, 2013
Last Update Posted : March 19, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Device: Micropulse laser treatment Device: Laser modified ETDRS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Between Treatment With Yellow Micropulse Laser and Green Conventional Laser in Diabetic Macular Edema|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||November 2014|
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.
- Mean change in visual acuity (ETDRS letters) [ Time Frame: 12 months ]
- Mean change in central retinal thickness [ Time Frame: 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 [ Time Frame: 12 months ]Percentage of patients that gain 1, 2, or 3 ETDRS lines of visual acuity
- Percentage of patients losing ETDRS lines [ Time Frame: 12 months ]PErcentage of patients that loose 1, 2, or 3 ETDRS lines of visual acuity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928654
|Contact: Andrea Giani, MD||+39023904 ext firstname.lastname@example.org|
|Contact: Antonio Caimi, MD||+39023904 ext email@example.com|
|Eye Clinic - Luigi Sacco University Hospital||Recruiting|
|Milan, Italy, 20157|
|Contact: Andrea Giani, MD +39023904 ext 2901 firstname.lastname@example.org|
|Contact: Antonio Caimi, MD +39023904 ext 2441 email@example.com|
|Sub-Investigator: Andrea Giani, MD|
|Principal Investigator: Giovanni Staurenghi, MD|
|Sub-Investigator: Luigi Bonavia, MD|
|Sub-Investigator: Antonio Caimi, MD|