Comparison of subthreshold diode laser micropulse therapy versus conventional photocoagulation laser therapy as primary treatment of diabetic macular edema in the years of 2015-2016 at the Isfahan Feiz hospital
Diabetic macular edema with foveal involvement is the most common cause of decrease vision in diabetic retinopathy patients. Diabetic macular edema is a resistance situation that completely resolving of the edema is nearly impossible.
Nowadays conventional laser photocoagulation is the gold standard treatment but it accompany with retinal image because of continuous laser use.
In attention to probable complications of laser photocoagulation newer methods with lesser damage were developed such as intra vitreal injection of anti-vascular endothelial growth factors and or steroids. Although these injections have had favorable results but they have their complications. For the best result of therapy, it needs to inject intra vitreal frequently, so it has the greater chance of complication and also greater cost.
Subthreshold diode micropulse laser is a newer method in treatment of diabetic macular edema but the effect of this method in relation to old conventional laser photocoagulation needs more studies.
We aimed in this randomized clinical trial to survey the effect of the subthreshold diode micropulse laser in comparison with the conventional laser photocoagulation in treatment of diabetic macular edema.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122721890N2
Registration date:2016-01-25, 1394/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-25, 1394/11/05
Registrant information
Name
Khodayar Golabchi
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5533 1151
Email address
kh_golabchi@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of subthreshold diode laser micropulse therapy versus conventional photocoagulation laser therapy as primary treatment of diabetic macular edema in the years of 2015-2016 at the Isfahan Feiz hospital
Public title
The effect of the laser photocoagulation method in treatment of diabetic macular edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: at least best corrected vision 20/200 or 1.00 LogMAR; the best corrected vision less than 20/25 or 0.10 LogMAR; diabetic macular edema with at least central macular thickness of 300 microns
Exclusion criteria: monocular patients; diabetic macular edema with central macular thickness more than 450 microns; pregnant patients; uncontrolled diabetes mellitus defined with fasting blood glucose (FBS) more than 300 mg/dl and or Hb A1c˃10 mg/dl; uncontrolled hypertension defined with systolic blood pressure SBP more than 160 mmHg and or diastolic blood pressure (DBP) more than 110 mmHg; any history of intra orbital surgery except uncomplicated cataract surgery with phacoemulsification method; any history of previously intra ocular injection; any history of previously conventional laser photocoagulation of retina or subthreshold diode micropulse laser; previously history of glaucoma or ocular hypertension; macular diseases like vitreo macular traction(VMT), Epi retinal Membrane (ERM), Age related macular degeneration (AMD), proliferative diabetic retinopathy (PDR); extensive non capillary perfusion in fundus angiography of macula; pregnancy during the study; any visible scar in ophthalmic examination or fundus angiography during the study in group that treated with subthreshold diode micropulse laser; not follow up of patients; no acceptance to perform study.
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Postal code
Approval date
2015-11-11, 1394/08/20
Ethics committee reference number
IR.MUI.REC.1394.3.629
Health conditions studied
1
Description of health condition studied
diabetic macular edema
ICD-10 code
H36.0
ICD-10 code description
Diabetic retinopathy (E10-E14 with common fourth character .3+)
Primary outcomes
1
Description
Best corrected visual acuity
Timepoint
0, ,2, 4 Months
Method of measurement
With Snellen chart and then converted to LogMAR
2
Description
The mean of central macular thickness
Timepoint
0, ,2, 4 Months
Method of measurement
With optical coherence tomography (OCT) imaging technique (Microns)
3
Description
The mean of central macular volume
Timepoint
0, ,2, 4 Months
Method of measurement
With optical coherence tomography (OCT) imaging technique (Microns)
Secondary outcomes
1
Description
Complications of the conventional laser photocoagulation
Timepoint
2, 4 Months
Method of measurement
Fundus examination and fluorescein angiography
2
Description
Complications of the subthreshold diode micropulse laser
Timepoint
2, 4 Months
Method of measurement
Fundus examination and fluorescein angiography
Intervention groups
1
Description
After getting informed consent we will be studied 68 eyes that randomly will divide in two groups.
First group will be get subthreshold diode micropulse laser photocoagulation (Quantel-medical Co, USA) as described below: adjustable power that begins of 1000 millivolt with duration time of 300 microseconds, 15 % of duty cycle and 75 to 125 microns spot size. All areas of thickened and edematous retina will be treated with distance of 100 microns of the FAZ in this method.
Category
Treatment - Devices
2
Description
Conventional laser photocoagulation (Quantel-medical Co, USA) will be performed via dilated pupil in eyes of second group as described below: adjustable power with 50 to 100 microns spot size, 0.1 second duration time. Focal laser will be applied in distance of 500 to 3000 microns of the foveal avascular zone (FAZ) and also on microvascular lesions of the exudative ring, also grid laser will be applied on thickened retinal areas in 500 microns distance of the FAZ and 500 microns distance of temporal ridge of optic disc.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz Eye Center Hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mahdi Nematbakhsh
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Majid Bagheri
Position
MD, Ophthalmology residdent
Other areas of specialty/work
Street address
Feiz Eye Center hospital, Modaress Street, Ghods Square, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3445 2033
Fax
Email
bagheri.majid0612@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Farhad Fazel
Position
Associated professor
Other areas of specialty/work
Street address
Feiz Eye Center Hospital, Ghods Square, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3445 2033
Fax
Email
fazel@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Khodayar Golabchi
Position
MD, Ophthalmology resident
Other areas of specialty/work
Street address
Feiz Eye Center Hospita, Ghods Sq., Isfahanl
City
Isfahan
Postal code
Phone
+98 31 3445 2033
Fax
Email
kh_golabchi@edc.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)