The TENDER Study (Dextenza Insert in Children)

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.

Who Can Participate?

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 Range

3-17

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

Evaluation of the safety and efficacy of Dextenza implant in pediatric patients following retinal surgery and laser therapy

Principal Investigator

Lejla
Vajzovic

Protocol Number

PRO00107533

NCT ID

NCT05620901

Phase

N/A

Enrollment Status

Open to Enrollment
ClinicalTrials.gov