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.
- 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?
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.
- 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.
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 ACCRUAL