Diabetic maculae edema. Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema
Conditions
Interventions
Intervention 1: Intervention group: Patients randomized to receive triamcinolone acetonide will be treated with an intravitreal injection of 2 milligrams (equivalent to 0.05 mL of a 40 mg/mL solution)
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Center involved diabetic macular edema Diabetic edema Mean central thickness =500 µm > 18 years diabetic patients BCVA between 20/40 and 20/400
Exclusion criteria
Exclusion criteria: History of Intraocular surgery in less than 4 months ago any patient with HR-PDR Prior treatment with intravitreal or peribulbar injections of triamcinolone within the preceding 3 months history of glaucoma or steroid induced high intraocular pressure. Hx of Intraocular surgery in less than 4 months ago Substantial cataract estimated to have reduced visual acuity by >3 lines No Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs Macular edema due to a cause other than diabetic retinopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity. Timepoint: Investigators measured Best Corrected Visual Acuity at baseline (pre-intervention) and monthly through Month 6 (assessing at each 30-day interval: Month 1, 2, 3, 4, 5, and 6). Method of measurement: A fully trained optometrist measured best-corrected visual acuity for each participant using a standard Snellen visual acuity chart.;Centeral Macular Thickness. Timepoint: Investigators measured Centeral Macular Thickness at baseline (pre-intervention) and monthly through Month 6 (assessing at each 30-day interval: Month 1, 2, 3, 4, 5, and 6). Optical coherence tomography. Method of measurement: A fully trained optometrist measured Centeral Macular Thickness for each eye by using Optical coherence tomography . | — |
Secondary
| Measure | Time frame |
|---|---|
| Intra ocular pressure. Timepoint: Intraocular pressure will be measured at baseline and then monthly throughout the six-month follow-up period. (baseline , and then at the first, second, third, fourth, fifth, and sixth months). Method of measurement: Intraocular pressure will be measured using the Goldmann applanation tonometer. The Goldmann tonometer is a standard and precise device for measuring intraocular pressure, operated by a trained technician to ensure reliable and accurate pressure recordings.;Cataract progression. Timepoint: Cataract progression will be assessed at baseline and then monthly from the first to the sixth month during the six-month follow-up period. (baseline , and then at the first, second, third, fourth, fifth, and sixth months). Method of measurement: Cataract will be evaluated using slit-lamp biomicroscopy by a trained ophthalmologist. Changes in lens opacity will be documented according to standardized grading scales to monitor any progression during the study. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAlireza Zare Mehrjardi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed