Clinical trial NCT01928654: Comparison Between Treatment With Yellow Micropulse Laser and Green Conventional Laser in Diabetic Macular Edema
Official title: Comparison Between Treatment With Yellow Micropulse Laser and Green Conventional Laser in Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Macular Edema
Keywords: Edema
Diabetic
Laser
Treatment
Lead sponsor: Luigi Sacco University Hospital
Sponsor class: OTHER
First posted: 2013-08-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Mean change in visual acuity (ETDRS letters)
timeFrame: 12 months
Secondary outcomes:
measure: Mean change in central retinal thickness
timeFrame: 12 months
measure: Percentage of patients gaining ETDRS lines
timeFrame: 12 months
measure: Percentage of patients losing ETDRS lines
timeFrame: 12 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Eye Clinic - Luigi Sacco University Hospital
Study officials:
References: