A 45 Day, Randomized, Trial of Dextenza in Pediatric Patients Undergoing Retinal Surgeries or Laser Treatments

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.

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 VitreoretinopathyCoats' DiseaseExudative RetinopathyLattice degenerationRetinal holesSickler's syndromeRetinal detachment, rhegmatogenousRetinal detachment, exudativeRetinal detachment, tractionalProceduresLaser photocoagulationCryotherapyRetinal detachment repair with scleral buckle and cryotherapyRetinal detachment repair with vitrectomyWritten informed consent from parent/legal guardianExclusion Criteria:PreproceduralActive or history of chronic or recurrent inflammatory eye disease in either eyeAny patient of reproductive potential that has a positive pregnancy test during pre-procedural testingActive or history of increased ocular pressurePatients with active corneal, conjunctival, and canalicular infectionsPatients with punctal stenosis or other punctal anatomical abnormalities that would not be conducive with device insertionNasolacrimal duct obstructionLaser or incisional ocular surgery during the study period and 6 months prior in the study eyecurrent use of systemic or topical steroids or NSAIDS on a regular basisHistory of autoimmune disease that may interfere with treatment/outcomesOcular pain at the time of screeningKnown malignancyCurrent use of cyclosporin or a TNF blockerOcular hypertension IOP >25, actively taking medications for ocular hypertension, any history of IOP spikes in either including steroid associated IOP elevationCongenital ocular lid and tear duct system abnormalities (e.g. congenital ectropion/entropion, trichiasis)Evidence of acute external ocular infection of the study eyeActive or history of HSVPrevious trauma causing deformityPrevious enrollment or current enrollment with another clinical trial within the last 30 days that may interfere with treatmentKnown allergies to product under investigationInability to engage in VA testingInvestigator determines that the candidate is not eligible for participation based on clinical or historical factors that would interfere with treatment or impact patient safety not specified aboveCurrent artificial tear use >4x dailyCurrent use of any topical ocular dropsAnyone who, in the opinion of the investigator, would not be a good candidate for the study.IntraoperativelyMultiple procedures requiredComplication occurs that surgeon determines makes the patient ineligible for study inclusionUnsuccessful dilation of the punctum to 0.7mm when dilation attemptedduring the exam under anesthesia, if it is decided that periocular Kenalog injection is indicated this patient fails screen and will no longer be eligible for the study