Eye Diseases, Injection Complication, Intraocular Pressure
Conditions
Keywords
anti-vascular endothelial growth factor, intraocular pressure, brinzolamide, brimonidine, fixed combination
Brief summary
This study aims to evaluate the effect of topical prophylaxis with brinzolamide-brimonidine fixed combination on short-term intraocular pressure (IOP) elevation after intravitreal injections of anti-vascular endothelial growth factors (anti-VEGF). Patients scheduled for treatment with intravitreal injections of anti-VEGF will be randomly divided into two groups. In control group no prophylactic medication will be used, whereas in case group one drop of brinzolamide-brimonidine fixed combination will be instilled two hours before the injection. IOP will be measured before the injection, 1 minute after the injection, 10 minutes and 30 minutes post-injection in all eyes. In case group, the pre-injection IOP will be measured prior to the administration of the fixed combination of brinzolamide-brimonidine. The iCare (IC200) tonometer will be used for IOP measurements at all time points.
Detailed description
The intravitreal anti-VEGF (ranibizumab, bevacizumab, pegaptanib and aflibercept) are commonly used in the treatment of diabetic macular edema, neovascular age-related macular degeneration and other pathologies characterized by retinal or choroidal neovascularization. Intravitreal injections οf anti-VEGF agents result in an immediate and transient increase in IOP, which returns to normal within a short period of time, typically within thirty minutes. Repeated intravitreal injections and prolonged treatments seem to be associated with sustained elevation of IOP, leading to the initiation of ocular hypotensive medication and glaucoma filtration surgery. A fixed-dose combination of brinzolamide 1%, a carbonic anhydrase inhibitor, and brimonidine 0,2%, an alpha 2 adrenergic receptor agonist, represents a safe and effective drug in glaucoma treatment and its ocular hypotensive effect has been demonstrated similar to or better than the unfixed combinations of its component drugs.
Interventions
In case group one drop of a fixed combination of brinzolamide-brimonidine will be instilled two hours before the injection
Sponsors
General Hospital of Athens Elpis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The investigator who will measure the IOP will be masked to group assignment.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for treatment with intravitreal injections of anti-vascular endothelial growth factors
Exclusion criteria
* history of glaucoma or ocular hypertension * use of topical medications (e.g. IOP-lowering medication, corticosteroids) * pseudoexfoliation * pigment dispersion syndrome * corneal diseases * active intraocular inflammation * any intraocular surgery in the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP at 1 minute post-injection | 1 minute post-injection | IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP at 10 minutes post-injection | 10 minutes post-injection | IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer) |
| IOP at 30 minutes post-injection | 30 minutes post-injection | IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer) |
Countries
Greece
Outcome results
None listed