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COMPLETED
NCT05620901
EARLY_PHASE1

DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia

Sponsor: Lejla Vajzovic, MD, FASRS

View on ClinicalTrials.gov

Summary

The Tender Study is a prospective, open-label, single-center, randomized, investigator-initiated clinical study seeks to investigate the safety and efficacy of the DEXTENZA insert in pediatric patients following retinal surgery or laser treatment under anesthesia.

Official title: The Evaluation of the Safety and Efficacy of Sustained Release Dexamethasone Intracanalicular Insert (DEXTENZA) in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (TENDER)

Key Details

Gender

All

Age Range

3 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2023-02-01

Completion Date

2025-02-24

Last Updated

2026-04-23

Healthy Volunteers

Yes

Interventions

DRUG

Dextenza 0.4Mg Ophthalmic Insert

DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use

DRUG

Pred Forte

To treat perioperative ocular inflammation and pain;

Locations (1)

Duke Eye Center

Durham, North Carolina, United States