DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (NCT05620901) | Clinical Trial Compass
CompletedEarly Phase 1
DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia
United States15 participantsStarted 2023-02-01
Plain-language summary
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.
Who can participate
Age range
3 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia for a variety of visual conditions. These conditions and procedures include but are not limited to:
Conditions:
* Familial Exudative Vitreoretinopathy
* Coats' Disease
* Exudative Retinopathy
* Lattice degeneration
* Retinal holes
* Sickler's syndrome
* Retinal detachment, rhegmatogenous
* Retinal detachment, exudative
* Retinal detachment, tractional
Procedures
* Laser photocoagulation
* Cryotherapy
* Retinal detachment repair with scleral buckle and cryotherapy
* Retinal detachment repair with vitrectomy
* Written informed consent from parent/legal guardian
Exclusion Criteria:
Preprocedural
* Active or history of chronic or recurrent inflammatory eye disease in either eye
* Any patient of reproductive potential that has a positive pregnancy test during pre-procedural testing
* Active or history of increased ocular pressure
* Patients with active corneal, conjunctival, and canalicular infections
* Patients with punctal stenosis or other punctal anatomical abnormalities that would not be conducive with device insertion
* Nasolacrimal duct obstruction
* Laser or incisional ocular surgery during the study period and 6 months prior in the study eye
* current use of systemic or topical steroids or NSAIDS on a regular basis
* History of autoimmune disease that may interfere with treatment/outcomes
* Ocular pain at the time of screening
* Known malignancy
* Current …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain as Measured by the FLACC Pain Scale
Timeframe: Baseline, post-op days 1, 7, 28, and 45