RECRUITING

Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.

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

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel

Official Title

Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) When Placed Within the Lower Eye Lid Canaliculus or Both the Upper and Lower Canaliculi for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.

Quick Facts

Study Start:2021-04-27
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04501367

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Symptomatic macular pucker with retinal edema
  2. * Age 18 years and older
  3. * Scheduled vitrectomy and internal limiting membrane peel
  4. * Willing and able to comply with clinic visits and study related procedures
  5. * Willing and able to sign the informed consent form
  1. * Patients under the age of 18
  2. * Pregnancy ( must be ruled out in women of child-bearing age with pregnancy test)
  3. * Active infectious systemic disease
  4. * Active infectious ocular or extraocular disease
  5. * Obstructed nasolacrimal duct in the study eye (s)
  6. * Hypersensitivity to dexamethasone or prednisolone eye drops
  7. * Patients being treated with immunomodulating agents in the study eye(s)
  8. * Patient being treated with immunosuppressants and/or oral steroids
  9. * Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Contacts and Locations

Study Contact

Saad Ahmad, MD
CONTACT
6308339361
ifixretinas@gmail.com
Jamie White, Bachelors
CONTACT
6308339621
jamie.white@kovacheye.com

Principal Investigator

Saad Ahmad, MD
PRINCIPAL_INVESTIGATOR
Kovach Eye Institute

Study Locations (Sites)

Kovach Eye Institute
Elmhurst, Illinois, 60126
United States

Collaborators and Investigators

Sponsor: Kovach Eye Institute

  • Saad Ahmad, MD, PRINCIPAL_INVESTIGATOR, Kovach Eye Institute

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 Date2021-04-27
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2021-04-27
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Vitrectomy
  • Macular Pucker
  • Retinal Edema