- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07826286
Changes in Intraocular Pressure After Intravitreal Injection
Monitoring Changes in Intraocular Pressure After Intravitreal Injection
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from Baseline in Intraocular Pressure at 1 Minute
Time Frame: Baseline and 1 minute post-injection
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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.
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Baseline and 1 minute post-injection
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Change from Baseline in Intraocular Pressure at 5 Minutes
Time Frame: Baseline and 5 minutes post-injection
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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.
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Baseline and 5 minutes post-injection
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Change from Baseline in Intraocular Pressure at 20 Minutes
Time Frame: Baseline and 20 minutes post-injection
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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.
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Baseline and 20 minutes post-injection
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Post-Intravitreal IOP Changes
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