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IRCT2015122721890N2 IRCT 2016-01-25 Vice Chancellor for Research, Isfahan University of Medical Sciences The effect of the laser photocoagulation method in treatment of diabetic macular edema 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 2015-11-22 anticipated 68 Complete https://irct.ir/trial/19037 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A diabetic macular edema. Intervention 1: 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. Intervention 2: 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.
public Dr. Majid Bagheri
Feiz Eye Center hospital, Modaress Street, Ghods Square, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 3445 2033 bagheri.majid0612@gmail.com Isfahan University of Medical Sciences scientific Dr. Farhad Fazel
Feiz Eye Center Hospital, Ghods Square, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 3445 2033 fazel@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) 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. 30 years no limit Both H36.0 Diabetic retinopathy (E10-E14 with common fourth character .3+) Treatment - Devices Treatment - Devices 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. 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. Best corrected visual acuity. Timepoint: 0, ,2, 4 Months. Method of measurement: With Snellen chart and then converted to LogMAR. The mean of central macular thickness. Timepoint: 0, ,2, 4 Months. Method of measurement: With optical coherence tomography (OCT) imaging technique (Microns). The mean of central macular volume. Timepoint: 0, ,2, 4 Months. Method of measurement: With optical coherence tomography (OCT) imaging technique (Microns). Complications of the conventional laser photocoagulation. Timepoint: 2, 4 Months. Method of measurement: Fundus examination and fluorescein angiography. Complications of the subthreshold diode micropulse laser. Timepoint: 2, 4 Months. Method of measurement: Fundus examination and fluorescein angiography. Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2015-11-11 Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Street Isfahan Iran (Islamic Republic of)