Determining the association of response rate to Intravitreal injection of bevacizumab and macular vessel density in patients with diabetic macular edema using optical coherence tomography angiography (OCT-A) in outpatients referred to Feyz Hospital. Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema
Conditions
Interventions
Intervention group: The present study is a longitudinal study with a pre-post design. Samples are selected sequentially from outpatients to ophthalmology clinics who have non-proliferative diabetic re
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age over 18 years Having type 1 or 2 diabetes Central macular edema based on Heidelberg's clinical examination and OCT in one or both eyes (at least 305 µm in women and 320 µm in men) Best modified view less than or equal to 10/7 No history of laser in the patient's eye Moderate to severe non-proliferative diabetic retinopathy with diabetic macular edema Transparent media to the extent that it does not interfere with the quality of images and their analysis (SSI: signal strength index: 37-40)
Exclusion criteria
Exclusion criteria: History of retinal vascular obstructive diseases History of intraocular injection in the last 6 months History of intraocular and retinal laser in the affected eye in the last 12 months Decreased vision following any ocular pathology other than diabetic retinopathy High Myopia (= -8) History of eye surgery in the last 6 months Uncontrolled glaucoma (IOP = 30 mmHg despite maximal treatment) Uncontrolled diabetes Uncontrolled blood pressure (SBP =180 mmHg or DBP =100 mmHg Connective tissue diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood sugar levels. Timepoint: Before the intervention. Method of measurement: blood test.;Blood pressure. Timepoint: Before the intervention. Method of measurement: Physical examination.;Severity of retinopathy. Timepoint: Before the intervention. Method of measurement: Examination with slit lamp.;The best modified vision. Timepoint: Before the intervention. Method of measurement: Physical examination.;Eye pressure. Timepoint: Before the intervention. Method of measurement: Measurement with tonometer.;The central thickness of the macula. Timepoint: Before the intervention and 1 month after the last injection. Method of measurement: OCT.;FAZ level. Timepoint: Before the intervention and 1 month after the last injection. Method of measurement: OCT-A.;Vascular density of the surface layer. Timepoint: Before the intervention and 1 month after the last injection. Method of measurement: OCT-A.;Deep layer vascular density. Timepoint: Before the intervention and 1 month after the last injection. Method of measurement: OCT-A.;Total vascular density. Timepoint: Before the intervention and 1 month after the last injection. Method of measurement: OCT-A. | — |
Secondary
| Measure | Time frame |
|---|---|
| The central thickness of the macula. Timepoint: One month after the last injection. Method of measurement: OCT.;FAZ level. Timepoint: One month after the last injection. Method of measurement: OCT-A.;Vascular density of the surface layer. Timepoint: One month after the last injection. Method of measurement: OCT-A.;Deep layer vascular density. Timepoint: One month after the last injection. Method of measurement: OCT-A.;Total vascular density. Timepoint: One month after the last injection. Method of measurement: OCT-A. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahya Ghazi
Esfahan University of Medical Sciences
Outcome results
None listed