Diabetic Macular Edema Clinical Trial
Official title:
Comparison Between Treatment With Yellow Micropulse Laser and Green Conventional Laser in Diabetic Macular Edema
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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