The Evaluation of the Safety and Efficacy of Sustained Release Dexamethasone Intracanalicular Insert (DEXTENZA) in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (TENDER)
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.
⁃ 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