The TENDER Study (Dextenza Insert in Children) - Clinical Trial
What is the Purpose of this Study?
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?
Ocular Inflammation and Pain After Retinal Surgery
Who Can Participate in the Study?
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?
If your child chooses to join the study, they will get a random assignment (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
Participants in both groups will:
- 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
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment