Diabetic Macular Edema
Conditions
Keywords
Edema, Diabetic, Laser, Treatment
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.
Interventions
DEVICELaser modified ETDRS
Device for visible treatment of the retina, with direct treatment of microaneurysms or grid pattern covering the area of retinal edema.
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.
Sponsors
Luigi Sacco University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in visual acuity (ETDRS letters) | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in central retinal thickness | 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 | 12 months | Percentage of patients that gain 1, 2, or 3 ETDRS lines of visual acuity |
| Percentage of patients losing ETDRS lines | 12 months | PErcentage of patients that loose 1, 2, or 3 ETDRS lines of visual acuity |
Countries
Italy
Contacts
Primary ContactAndrea Giani, MD
Backup ContactAntonio Caimi, MD
Outcome results
None listed