Diabetic Macular Edema Clinical Trial
Official title:
Anatomical and Functional Outcomes of Subthreshold Micropulse Laser Versus Intravitreal Ranibizumab Injection in Treatment of Diabetic Macular Edema
The aim of this study is To compare the anatomical and functional results of intravitreal( IV) injection of ranibizumab with sub threshold micropulse laser ( SML) in treatment of Diabetic macular edema (DME) both anatomically by spectral domain optical coherence tomography (SD OCT) and functionally by best-corrected visual acuity (BCVA) and multifocal electroretinogram (mfERG).
Diabetic macular edema (DME) causes significant visual loss in diabetic patients. About 20%
and 40% of patients with Type 1 and Type 2 diabetes mellitus (DM), respectively, develop DME.
One-third of diabetic patients who have had DM for more than twenty years will develop DME .
Early impairment in the function of the middle and inner layers of the retina has been
reported in diabetic patients before appearance of vascular complications . A good
independent guide of macular function in patients with DME is multifocal electroretinogram
(mfERG) readings from the macular area, which strongly associate with morphologic alterations
in the macula. Some investigators suggested that temporal characteristic (implicit time) of
mfERG waves are more important than amplitudes for evaluation of retinal function in diabetic
patients. They concluded that patients with DM show temporal changes indicating delayed
neural transmission due to local impairment of blood glucose metabolism. In contrast, others
emphasize the importance of both parameters (implicit time and amplitude) in identifying
retinal affection in DM.
Intravitreal (IV) injections of anti-vascular endothelial growth factor (VEGF) agents
provided good visual outcomes in treatment of DME. However, IV anti-VEGF injections are
expensive, need to be repeated many times and have the potential risk of causing
endophthalmitis . Subthreshold micropulse laser (SML) treatment of DME has the same effect as
conventional laser treatment, nonetheless, there is less damage to adjacent tissues of the
burn area in the retinal pigment epithelium (RPE). SML allows laser emission to be divided
into bursts of short cyclic pulses that remain for microseconds permitting substantial
cooling amid these short pulses .
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