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 range3 Years – 17 Years
SexALL
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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 …
What they're measuring
1
Pain as Measured by the FLACC Pain Scale
Timeframe: Baseline, post-op days 1, 7, 28, and 45