The TENDER Study (Dextenza Insert in Children) - Clinical Trial

What is the Purpose of this Study?

Treatment

We are doing this study to find out if an ophthalmic insert called Dextenza can be used to control eye inflammation and pain in pediatric patients after routine retinal surgery or laser treatment.

What is the Condition Being Studied?
Objective

Ocular Inflammation and Pain After Retinal Surgery

Who Can Participate in the Study?

Key Eligibility

Children ages 3-17 who:
- Will have a routine retinal surgery or laser treatment under anesthesia
- Do not have an inflammatory eye disease
- Do not have elevated eye pressure

For more information about who can join this study, please contact the study team at DEC-RA@duke.edu.

Age Group
Children

What is Involved?

Description

If your child chooses to join the study, they will:
- Be randomly assigned (like drawing numbers from a hat) to 1 of 2 groups
-- One group will get the Dextenza insert
-- The other group will be treated with steroid drops after surgery
- Keep in touch with the study team for about 2 months after their surgery
- Visit our clinic at the Duke Eye Center up to 5 times.

At various visits, your child will have eye exams and vision tests during the study.

Study Details

Full Title
Evaluation of the safety and efficacy of Dextenza implant in pediatric patients following retinal surgery and laser therapy
Principal Investigator
Ophthalmologist
Protocol Number
IRB: PRO00107533
NCT: NCT05620901
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment