COMPLETED

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

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Conditions

VitreoretinopathyCoats' DiseaseExudative RetinopathyLattice DegenerationRetinal HoleSickler's SyndromeRetinal Detachment RhegmatogenousRetinal Detachment ExudativeRetinal Detachment Traction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2023-02-01
Study Completion:2025-02-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05620901

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.

Ages Eligible for Study:3 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Familial Exudative Vitreoretinopathy
  2. * Coats' Disease
  3. * Exudative Retinopathy
  4. * Lattice degeneration
  5. * Retinal holes
  6. * Sickler's syndrome
  7. * Retinal detachment, rhegmatogenous
  8. * Retinal detachment, exudative
  9. * Retinal detachment, tractional
  10. * Laser photocoagulation
  11. * Cryotherapy
  12. * Retinal detachment repair with scleral buckle and cryotherapy
  13. * Retinal detachment repair with vitrectomy
  14. * Written informed consent from parent/legal guardian
  1. * Active or history of chronic or recurrent inflammatory eye disease in either eye
  2. * Any patient of reproductive potential that has a positive pregnancy test during pre-procedural testing
  3. * Active or history of increased ocular pressure
  4. * Patients with active corneal, conjunctival, and canalicular infections
  5. * Patients with punctal stenosis or other punctal anatomical abnormalities that would not be conducive with device insertion
  6. * Nasolacrimal duct obstruction
  7. * Laser or incisional ocular surgery during the study period and 6 months prior in the study eye
  8. * current use of systemic or topical steroids or NSAIDS on a regular basis
  9. * History of autoimmune disease that may interfere with treatment/outcomes
  10. * Ocular pain at the time of screening
  11. * Known malignancy
  12. * Current use of cyclosporin or a TNF blocker
  13. * Ocular hypertension IOP \>25, actively taking medications for ocular hypertension, any history of IOP spikes in either including steroid associated IOP elevation
  14. * Congenital ocular lid and tear duct system abnormalities (e.g. congenital ectropion/entropion, trichiasis)
  15. * Evidence of acute external ocular infection of the study eye
  16. * Active or history of HSV
  17. * Previous trauma causing deformity
  18. * Previous enrollment or current enrollment with another clinical trial within the last 30 days that may interfere with treatment
  19. * Known allergies to product under investigation
  20. * Inability to engage in VA testing
  21. * 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
  22. * Current artificial tear use \>4x daily
  23. * Current use of any topical ocular drops
  24. * Anyone who, in the opinion of the investigator, would not be a good candidate for the study.
  25. * Multiple procedures required
  26. * Complication occurs that surgeon determines makes the patient ineligible for study inclusion
  27. * Unsuccessful dilation of the punctum to 0.7mm when dilation attempted
  28. * 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

Contacts and Locations

Principal Investigator

Lejla Vajzovic, MD
PRINCIPAL_INVESTIGATOR
Duke Eye Center

Study Locations (Sites)

Duke Eye Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Lejla Vajzovic, MD, FASRS

  • Lejla Vajzovic, MD, PRINCIPAL_INVESTIGATOR, Duke Eye Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01
Study Completion Date2025-02-24

Study Record Updates

Study Start Date2023-02-01
Study Completion Date2025-02-24

Terms related to this study

Additional Relevant MeSH Terms

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