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The effect of the laser photocoagulation method in treatment of diabetic macular edema

Not Applicable
Conditions
diabetic macular edema.
Diabetic retinopathy (E10-E14 with common fourth character .3+)
Registration Number
IRCT2015122721890N2
Lead Sponsor
Vice Chancellor for Research, Isfahan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
68
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

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.
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