Changes in Intraocular Pressure After Intravitreal Injection

NCT07826286 — Not yet recruiting, 50 participants, Assiut University

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Monitoring Changes in Intraocular Pressure After Intravitreal Injection

RegistryNCT07826286
StatusNot yet recruiting
Study typeObservational
Enrollment50 (Estimated)
SponsorAssiut University (Other)
ConditionsDiabetic Macular Edema, Neovascular Age-Related Macular Degeneration, Retinal Vein Occlusion, Ocular Hypertension
Datesstart 2026-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2027-11-01 (estimated), first posted 2026-09-17, last updated 2026-09-17

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-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Intravitreal Anti-VEGF Injection CohortPatients 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.

+Outcome measures

Primary outcomes

  • Change from Baseline in Intraocular Pressure at 1 Minute [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 [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 [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.

+Eligibility

Sex: All, ages: 18 Years to any

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.