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NCT04371445 · ClinicalTrials.gov registry record · Phase 4

Dextenza in the Post-op Management of Vitreoretinal Surgeries

A Phase 4 study of Post Operative Pain and Ocular Inflammation, sponsored by The Cleveland Clinic.

Recruiting
Registry status
Phase 4
Development phase
30
Enrollment target
1
Study location

NCT04371445 is a Phase 4 study of Post Operative Pain and Ocular Inflammation that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 30 participants, below the 236-participant average among 56 other Post Operative Pain trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04371445, a Phase 4 study of Post Operative Pain and Ocular Inflammation, is actively recruiting participants, sponsored by The Cleveland Clinic.

RECRUITING
Registry status
Phase 4
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group. Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Interventions

  • DRUG Dexamethasone Ophthalmic Insert
  • DRUG Prednisolone Acetate 1% Oph Susp

Study Locations (1)

Ohio

  • Cole Eye Institute, Cleveland Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2020-06-01
Est. Completion 2026-05-01
Phase Phase 4

Sponsor

The Cleveland Clinic

688 total trials

What the Registry Record Tells You About NCT04371445

The ClinicalTrials.gov registry entry for NCT04371445 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 236-participant average among 56 other Post Operative Pain trials with a reported enrollment target (87% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Post Operative Pain appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone Ophthalmic Insert is the first listed.

NCT04371445 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT04371445 about?

NCT04371445 is a clinical study titled "Dextenza in the Post-op Management of Vitreoretinal Surgeries". This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group. Patients must be 18 years of age and older, of any race and...

What is the current status of trial NCT04371445?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2020-06-01. Estimated completion is 2026-05-01.

What conditions does trial NCT04371445 study?

This clinical trial studies the following conditions: Post Operative Pain, Ocular Inflammation, Post-Operative Inflammation, Vitreoretinal Surgery.

What interventions are being tested in trial NCT04371445?

The interventions under investigation include: Dexamethasone Ophthalmic Insert (DRUG), Prednisolone Acetate 1% Oph Susp (DRUG).

Who is sponsoring clinical trial NCT04371445?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04371445 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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