RECRUITING

Dextenza in the Post-op Management of Vitreoretinal Surgeries

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Conditions

Vitreoretinal SurgeryOcular InflammationPost-operative PainPost-Operative Inflammationdexamethasone insert

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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

This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group. Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Official Title

Intracanalicular Dexamethasone Insert for Management of Post-operative Pain and Inflammation in Patients Undergoing Vitreoretinal Surgery

Quick Facts

Study Start:2020-06-01
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04371445

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. * Men and women \>18 years old
  2. * Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.
  1. * Patients undergoing combined cataract or glaucoma procedure, intraocular lens exchange, scleral buckle, and/or implant of a drug delivery system
  2. * History of complications, trauma, adverse events, disease in nasolacrimal region, including dacryocystitis, canaliculitis in either eye
  3. * Structural lid abnormalities such as ectropion or entropion in surgical eye
  4. * Ongoing use of systemic narcotic pain relievers
  5. * Presence of any intraocular inflammation (cells and flare) in the study eye at screening/baseline
  6. * Pain score greater than "0" on the ocular pain assessment in the study eye at screening/baseline
  7. * Active or chronic or recurrent uncontrolled ocular or systemic inflammatory disease, including diabetes
  8. * Other ocular surgeries or procedures during the study period and/or 6 months prior
  9. * Intraoperative complications
  10. * Patients with history of glaucoma (defined as glaucoma requiring 2 or more drops, IOP at baseline greater than 25, or advanced optic nerve cupping). Patients with glaucoma or ocular hypertension controlled with a single drop can be enrolled.
  11. * Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication.
  12. * Have used ocular, topical, or systemic NSAIDs within 7 days prior to procedure and during surgery.
  13. * Use of intracameral or subconjunctival NSAIDs or steroids intraoperatively.
  14. * Have used topical, ocular, inhaled or systemic steroids within 14 days prior to procedure
  15. * Are pregnant or nursing/lactating
  16. * Participation as a subject in any clinical study within the 30 days prior to randomization.
  17. * Surgeries using 20 gauge or 23 gauge instruments.

Contacts and Locations

Study Contact

Katherine Talcott, M.D.
CONTACT
440 988-4040
talcotk@ccf.org
Angela Meador, MHA
CONTACT
216-445-7176
meadora@ccf.org

Principal Investigator

Katherine Talcott, M.D.
PRINCIPAL_INVESTIGATOR
Cole Eye Institute, Cleveland Clinic

Study Locations (Sites)

Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Katherine Talcott, M.D., PRINCIPAL_INVESTIGATOR, Cole Eye Institute, Cleveland Clinic

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 Date2020-06-01
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2020-06-01
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • dexamethasone insert
  • Ocular Inflammation
  • Post-Operative Inflammation
  • Post-operative Pain

Additional Relevant MeSH Terms

  • Vitreoretinal Surgery
  • Ocular Inflammation
  • Post-operative Pain
  • Post-Operative Inflammation