Evaluation of the Effects of Selective Photocoagulation for the Treatment of Diabetic Macular Edema (SRT)
The population of people suffering from diabetes is rapidly increasing, from an estimated 110 million in 1994 to 221 million in 2010. Diabetic macular edema is the most common reason for reduction in visual acuity in diabetic patients.
The standard care for diabetic macular edema is focal and /or grid retinal photocoagulation. During photocoagulation, small laser burns are applied to the retina, the sensory tissue that lines the back of the eye. Studies have shown that photocoagulation of clinically significant diabetic macular edema substantially reduces the risk of visual loss, increase the chance of visual improvement and decrease the frequency of persistent macular edema. However, it remains unknown whether the destruction of sensory layer of the retina during photocoagulation that may cause visual field defects is necessary for successful treatment or is just an unwanted and unnecessary side effect.
Based on these concept, a photocoagulation technique was developed to treat the retina selectively (SRT - Selective retinal therapy), with minimal or no damage to the sensory layers. While the treatment is very similar to regular photocoagulation, the SRT laser uses much lower energy and very short pulses. As a result, treatment does not result in visible burns to the retina and previous studies have shown that the sensory layer remains intact.
The aim of this study is to determine the effect of SRT on the resolution of the edema.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Multi Center Study Study of the Effects of Selective Retinal Photocoagulation for the Treatment of Diabetic Macular Edema|
- progression of macular edema [ Time Frame: 12months ] [ Designated as safety issue: No ]Proportion progressing to center involved macular edema by month 12 as confirmed on SD-OCT
|Study Start Date:||December 2009|
|Study Completion Date:||July 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
|Experimental: Laser therapy||
Device: Nd: YLF laser treatment
grid selective retinal treatment
Other Name: SRT
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355692
|Tel Aviv Sourasky Medical Center|
|Tel Aviv, Israel, 64329|
|Sheba Medical Center|
|Tel Hahsomer, Israel, 52621|
|Study Director:||Anat Loewenstein, MD||Tel-Aviv Sourasky Medical Center|
|Study Director:||Joseph Moisseiev, Prof.||Sheba Medical Center|