Diabetic retinopathy
Conditions
Interventions
This is a double-blind, randomized controlled clinical trial. Experimental group: 50 eyes of patients with diabetic retinopathy will receive an intravitreal injection of bevacizumab with a syringe wit
Sponsors
Hospital de Olhos de Sergipe
SJJ Solutions
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Over 18 years of age; both sexes; diabetic retinopathy, with indication for intravitreal injection of bevacizumab; clear ocular media and adequate pupillary dilation in both eyes to allow for all imaging procedures; visual acuity between 20/25 and 20/400; provide written consent; availability to come for exam 3 days after first injection and monthly for new exams and injection for 6 months
Exclusion criteria
Exclusion criteria: Severe glaucoma; age-related macular degeneration or retinal dystrophy; previous or current history of uveitis; previous vitreoretinal surgery; systemic contraindication to antiangiogenic therapy; presence of intraocular inflammation; any intraocular surgery in the previous 3 months; any eye infection; pregnancy or breastfeeding; any of the following conditions: severe heart disease, significant peripheral vascular disease; stroke in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Silicone oil is expected to be found in the vitreous of patients treated with the oil-free syringe in 5 to 10% of eyes while 15 to 20% in those treated with the siliconized syringe, as assessed by slit lamp examination. Data will be collected monthly after each injection, until the 6th injection is completed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate whether there will be a difference in anterior chamber reaction (inflammation) with the use of the oil-free syringe compared with the siliconized syringe, assessed by slit lamp examination. Data will be collected only on the day of the first injection and 72 hours later. | — |
Countries
Brazil
Contacts
Public ContactGustavo Melo
Hospital de Olhos de Sergipe
Outcome results
None listed