Clinical study to detect the presence of silicone oil released by syringes used for intraocular injectio
- Conditions
- Diabetic retinopathy
- Registration Number
- RBR-10tn82jt
- Lead Sponsor
- Hospital de Olhos de Sergipe
- Brief Summary
The rate of eyes with silicone oil droplets detected in the vitreous will be reported in the comparison of the groups. Likewise, the rate of eyes with anterior chamber cells will be reported for both groups
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.