NCT07826286

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Nov 2027

First Submitted

Initial submission to the registry

September 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 13, 2026

Last Update Submit

September 13, 2026

Conditions

Keywords

Intraocular PressureIntravitreal InjectionsAnti-VEGFIcare TonometryRebound TonometryBevacizumabRanibizumab

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline in Intraocular Pressure at 1 Minute

    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.

    Baseline and 1 minute post-injection

  • Change from Baseline in Intraocular Pressure at 5 Minutes

    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.

    Baseline and 5 minutes post-injection

  • Change from Baseline in Intraocular Pressure at 20 Minutes

    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.

    Baseline and 20 minutes post-injection

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients attending the Ophthalmology Department at El Mabara Hospital in Assiut, Egypt, who are scheduled to receive routine intravitreal anti-VEGF injections for vitreoretinal conditions such as diabetic macular edema, neovascular age-related macular degeneration, or retinal vein occlusion.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Retinal Vein OcclusionOcular Hypertension

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Ophthalmology

Study Record Dates

First Submitted

September 13, 2026

First Posted

September 17, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 17, 2026

Record last verified: 2026-09