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Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery | Clinical Trials | Clareo Health

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Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Drop Regimen Treating Pain and inflamMation Following Cataract Surgery Compared to SOC Topical Drop Regimen

NCT05626478•Nicole Fram M.D.

View on ClinicalTrials.gov

Summary

Detailed Description

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Prednisolone Acetate 1%.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosed with clinically significant cataract and are planning to undergo non-complicated Clear Cornea Incision Cataract Extraction with Posterior Capsule IntraOcular Lens in one or both eyes
•Are willing and able to comply with clinic visits and study related procedures
•Are willing and able to sign the informed consent form

Exclusion Criteria

•Under the age of 18 at the time of signing the Informed Consent Form
•Pregnant or planning to become pregnant during the trial period
•Have visual acuity potential of less than 20/30 as recorded by a Retinal Acuity Meter or Potential Acuity Meter glare testing
•Have active infectious systemic disease
•Have active infectious ocular or extraocular disease
•Have punctal plug in the study eye
•Have obstructed nasolacrimal duct in the study eye(s) (dacryocystitus)
•Have known hypersensitivity to dexamethasone or are a known steroid responder
•Have a history of ocular inflammation or macular edema
•Has history of Laser Vision Correction (LASIK, PhotoRefractive Keratectomy) in the operated eye
+8 more criteria

Locations (1)

Advanced Vision Care

Los Angeles, California, United States

Key Dates

Start Date

June 1, 2023

Primary Completion Date

February 5, 2025

Completion Date

February 5, 2025

Last Updated

February 20, 2026

Enrollment

ACTUAL participants

Conditions

Corneal EdemaCorneal DefectAnterior Chamber InflammationOcular PainCorneal StainingVisual OutcomeCME - Cystoid Macular Edema

Interventions

Dextenza 0.4Mg Ophthalmic Insert

DRUG

Prednisolone Acetate 1% Oph Susp

DRUG

Prolensa 0.07% Ophthalmic Solution

DRUG

The Belgian Endothelial Surgical Transplant of the Cornea

NCT05436665

Corneal EdemaCorneal Endothelial Disorder+3 more

View study

RECRUITING

Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema

NCT06983652

Corneal DiseasesCorneal Scars and Opacities+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Inclusion Criteria

Exclusion Criteria

The Belgian Endothelial Surgical Transplant of the Cornea

Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema

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