- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Studietyp
Inskrivning (Beräknad)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change from Baseline in Intraocular Pressure at 1 Minute
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Post-Intravitreal IOP Changes
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