Dextenza for Post-Retinal Surgery Care in Children
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop using any systemic or topical steroids, NSAIDs (non-steroidal anti-inflammatory drugs), cyclosporin, TNF blockers, and any topical ocular drops before participating.
Is Dextenza safe for use in children after eye surgery?
How is the drug Dextenza different from other treatments for post-retinal surgery care in children?
What data supports the effectiveness of the drug Dextenza 0.4Mg Ophthalmic Insert for post-retinal surgery care in children?
Who Is on the Research Team?
Lejla Vajzovic, MD
Principal Investigator
Duke Eye Center
Are You a Good Fit for This Trial?
This trial is for children needing retinal surgery or laser treatment under anesthesia. They must have conditions like Retinal Detachment, Lattice Degeneration, and others. Kids can't join if they have eye inflammation history, are pregnant, have increased eye pressure, infections, recent surgeries, use certain drugs or steroids, autoimmune diseases, ocular pain at screening time.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the Dextenza insert intraoperatively or Prednisolone forte 1% steroid drops post-operatively for perioperative ocular inflammation and pain
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events, inflammation, and pain
What Are the Treatments Tested in This Trial?
Interventions
- Dextenza 0.4Mg Ophthalmic Insert
- Pred Forte
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lejla Vajzovic, MD, FASRS
Lead Sponsor
Duke University
Lead Sponsor