Monitoring Changes in Intraocular Pressure After Intravitreal Injection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Change from Baseline in Intraocular Pressure at 1 Minute
研究概览
简要总结
Intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections introduce additional fluid volume into the eye, which can cause an acute, transient elevation in intraocular pressure (IOP). The purpose of this prospective observational study is to evaluate the immediate and early changes in intraocular pressure following intravitreal anti-VEGF injections and to determine how rapidly pressure recovers toward baseline levels.
Adult participants scheduled to receive routine intravitreal anti-VEGF therapy for established clinical indications, such as diabetic macular edema, neovascular age-related macular degeneration, or retinal vein occlusion, will be enrolled. Intraocular pressure will be measured using an Icare rebound tonometer with single-use disposable probes before injection (baseline) and at 1 minute, 5 minutes, and 20 minutes post-injection. The study will also analyze whether factors such as refractive error, the number of prior injections, or the type of anti-VEGF drug administered affect the severity of post-injection pressure spikes and subsequent recovery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Scheduled to receive an intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection for an established clinical indication (e.g., diabetic macular edema, neovascular age-related macular degeneration, or retinal vein occlusion).
- •Provision of written informed consent prior to enrollment.
排除标准
- •Known history of glaucoma or ocular hypertension.
- •History of previous glaucoma surgery.
- •Corneal diseases or ocular conditions that significantly interfere with accurate intraocular pressure measurement.
- •Inability to cooperate adequately during intraocular pressure measurement.
- •Refusal to participate or failure to provide informed consent.
- •Development of marked intraocular pressure elevation immediately after injection (IOP ≥ 40 mmHg) requiring anterior chamber paracentesis.
研究组 & 干预措施
Intravitreal Anti-VEGF Injection Cohort
Patients aged 18 years and older scheduled to receive an intravitreal anti-VEGF injection for established clinical indications, including diabetic macular edema, neovascular age-related macular degeneration, or retinal vein occlusion. Participants undergo baseline ophthalmic evaluation followed by intraocular pressure (IOP) monitoring at 1 minute, 5 minutes, and 20 minutes post-injection using an Icare rebound tonometer.
结局指标
主要结局
Change from Baseline in Intraocular Pressure at 1 Minute
时间窗: Baseline and 1 minute post-injection
Intraocular pressure will be measured in mmHg using an Icare rebound tonometer with a single-use disposable probe to assess the acute post-injection pressure spike compared to baseline.
Change from Baseline in Intraocular Pressure at 5 Minutes
时间窗: Baseline and 5 minutes post-injection
Intraocular pressure will be measured in mmHg using an Icare rebound tonometer with a single-use disposable probe to evaluate early post-injection pressure trends.
Change from Baseline in Intraocular Pressure at 20 Minutes
时间窗: Baseline and 20 minutes post-injection
Intraocular pressure will be measured in mmHg using an Icare rebound tonometer to assess the rate and extent of pressure recovery toward pre-injection baseline levels.
次要结局
未报告次要终点
研究者
Esraa Hussein Ali
Resident of Ophthalmology
Assiut University