diabetic macular edema. Diabetic retinopathy (E10-E14 with common fourth character .3+)
Conditions
Interventions
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
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, US
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 sec
Sponsors
Vice Chancellor for Research, Isfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to No maximum
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Majid Bagheri
Isfahan University of Medical Sciences
Outcome results
None listed