Comparison Between Treatment With Yellow Micropulse Laser and Green Conventional Laser in Diabetic Macular Edema

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Luigi Sacco University Hospital
Sponsor:
Information provided by (Responsible Party):
Giovanni Staurenghi, Luigi Sacco University Hospital
ClinicalTrials.gov Identifier:
NCT01928654
First received: August 21, 2013
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Diabetic Macular Edema
Device: Micropulse laser treatment
Device: Laser modified ETDRS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between Treatment With Yellow Micropulse Laser and Green Conventional Laser in Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Luigi Sacco University Hospital:

Primary Outcome Measures:
  • Mean change in visual acuity (ETDRS letters) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in central retinal thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of patients that gain 1, 2, or 3 ETDRS lines of visual acuity

  • Percentage of patients losing ETDRS lines [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    PErcentage of patients that loose 1, 2, or 3 ETDRS lines of visual acuity


Estimated Enrollment: 32
Study Start Date: July 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Micropulse laser treatment
Sub-threshold laser treatment covering the area of retinal thickening with a dense pattern
Device: Micropulse laser treatment
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.
Active Comparator: Laser modified ETDRS
Macular treatment using the modified ETDRS protocol, with barely visible laser burns to close microaneurysms, or with a grid pattern in the area of retinal thickening.
Device: Laser modified ETDRS
Device for visible treatment of the retina, with direct treatment of microaneurysms or grid pattern covering the area of retinal edema.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01928654

Contacts
Contact: Andrea Giani, MD +39023904 ext 2901 andrea.giani@unimi.it
Contact: Antonio Caimi, MD +39023904 ext 2441 antonio.caimi@gmail.com

Locations
Italy
Eye Clinic - Luigi Sacco University Hospital Recruiting
Milan, Italy, 20157
Contact: Andrea Giani, MD    +39023904 ext 2901    andrea.giani@unimi.it   
Contact: Antonio Caimi, MD    +39023904 ext 2441    antonio.caimi@gmail.com   
Sub-Investigator: Andrea Giani, MD         
Principal Investigator: Giovanni Staurenghi, MD         
Sub-Investigator: Luigi Bonavia, MD         
Sub-Investigator: Antonio Caimi, MD         
Sponsors and Collaborators
Luigi Sacco University Hospital
  More Information

No publications provided

Responsible Party: Giovanni Staurenghi, MD, Luigi Sacco University Hospital
ClinicalTrials.gov Identifier: NCT01928654     History of Changes
Other Study ID Numbers: Lasercomparison
Study First Received: August 21, 2013
Last Updated: March 18, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Luigi Sacco University Hospital:
Edema
Diabetic
Laser
Treatment

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 01, 2014