DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia

Description

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.

Conditions

Vitreoretinopathy, Coats' Disease, Exudative Retinopathy, Lattice Degeneration, Retinal Hole, Sickler's Syndrome, Retinal Detachment Rhegmatogenous, Retinal Detachment Exudative, Retinal Detachment Traction

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Study Overview

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Study Details

Study overview

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.

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)

DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia

Condition
Vitreoretinopathy
Intervention / Treatment

-

Contacts and Locations

Durham

Duke Eye Center, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Familial Exudative Vitreoretinopathy
  • * Coats' Disease
  • * Exudative Retinopathy
  • * Lattice degeneration
  • * Retinal holes
  • * Sickler's syndrome
  • * Retinal detachment, rhegmatogenous
  • * Retinal detachment, exudative
  • * Retinal detachment, tractional
  • * Laser photocoagulation
  • * Cryotherapy
  • * Retinal detachment repair with scleral buckle and cryotherapy
  • * Retinal detachment repair with vitrectomy
  • * Written informed consent from parent/legal guardian
  • * 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 use of cyclosporin or a TNF blocker
  • * Ocular hypertension IOP \>25, actively taking medications for ocular hypertension, any history of IOP spikes in either including steroid associated IOP elevation
  • * Congenital ocular lid and tear duct system abnormalities (e.g. congenital ectropion/entropion, trichiasis)
  • * Evidence of acute external ocular infection of the study eye
  • * Active or history of HSV
  • * Previous trauma causing deformity
  • * Previous enrollment or current enrollment with another clinical trial within the last 30 days that may interfere with treatment
  • * Known allergies to product under investigation
  • * Inability to engage in VA testing
  • * Investigator 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 above
  • * Current artificial tear use \>4x daily
  • * Current use of any topical ocular drops
  • * Anyone who, in the opinion of the investigator, would not be a good candidate for the study.
  • * Multiple procedures required
  • * Complication occurs that surgeon determines makes the patient ineligible for study inclusion
  • * Unsuccessful dilation of the punctum to 0.7mm when dilation attempted
  • * during 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

Ages Eligible for Study

3 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Duke University,

Lejla Vajzovic, MD, PRINCIPAL_INVESTIGATOR, Duke Eye Center

Study Record Dates

2024-04