Clinical trial NCT02474225: Intraocular Pressure Change Following Intravitreal Injection of Anti-vascular Endothelial Growth Factor Agent
Official title: Intraocular Pressure Change Following Intravitreal Injection of Anti-vascular Endothelial Growth Factor Agent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure
Keywords: intraocular pressure
intravitreal
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients scheduled to receive intravitreal injection of anti-vascular endothelial growth factor agent (either bevacizumab or ranibizumab) and were recruited.

Brief summary: The introduction of additional fluid into the vitreous cavity by intravitreal therapy would be expected to cause an immediate rise in the intraocular pressure. This transient, short-term intraocular pressure elevation (lasting up to 30 minutes) after intravitreal anti-vascular endothelial growth factor therapy has been well describe. The investigators aim to study the prevalence of the sustained intraocular pressure elevation associated with intravitreal injection of anti-vascular endothelial growth factor agents.

Detailed description: Intravitreal injections of anti-vascular endothelial growth factor agents are commonly used to treat a variety of retinal and choroidal neovascular diseases. The introduction of additional fluid into the vitreous cavity by intravitreal therapy would be expected to cause an immediate rise in the intraocular pressure.

Although there is one study showed no significant changes in the intraocular pressure many retrospective studies showed the impacts on the intraocular pressure elevation. The investigators aim to prospective evaluate the intraocular pressure change in non-glaucomatous patients receiving an intravitreal anti-vascular endothelial growth factor therapy.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to receive intravitreal injection of anti-vascular endothelial growth factor agent (either bevacizumab or ranibizumab), and
* Age of 18-85 year-old, and
* Initial intraocular pressure \< 21 mmHg

Exclusion Criteria:

* Diagnosis of open angle, or
* Diagnosis of angle-closure glaucoma, or
* Diagnosis of glaucoma suspect (intraocular pressure \> 21 mmHg on 2-consecutive visit and/or cup to disc ratio \> 0.5) , or
* Currently receive systemic beta-blocker
* Previously received intravitreal injection of anti-vascular endothelial growth factor agent
* Previously received intravitreal injection of steroid or gancyclovir
* Current use of steroid eye drop
* Any ocular surface disease preclude a reliable intraocular pressure measurement

Primary outcomes:
measure: Change from baseline in intraocular pressure
timeFrame: 6-month after injection
Secondary outcomes:
measure: Number of anti-glaucoma used
timeFrame: 6-month
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: Weerawat Kiddee
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Asst.Prof.Weerawat Kiddee, MD
role: PRINCIPAL_INVESTIGATOR
References: