RECRUITING

The PRIME Study: A Randomized, Controlled, Prospective Study

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Conditions

Patient PreferencePatient OutcomesPost-Operative InflammationGrade of Post-Operative Cystoid Macular EdemaRate of Post-Operative Cystoid Macular Edema

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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

To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.

Official Title

A Randomized, Controlled, PRospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the treatMEnt of Post-operative Inflammation in Patients Who Plan to Undergo Refractive Lens Exchange (RLE)

Quick Facts

Study Start:2020-09-14
Study Completion:2021-08-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04549935

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:22 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
  2. * Willing and able to comply with clinic visits and study related procedures
  3. * Willing and able to sign the informed consent form
  1. * Patients under the age of 22 or above the age of 75
  2. * Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
  3. * Patients with active infectious ocular or extraocular disease.
  4. * Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
  5. * Paitents with know hypersensitivity to Dexamethasone
  6. * Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator
  7. * Patients with a history of ocular inflammation or macular edema
  8. * Patients with allergy or inability to receive intracameral antibiotic
  9. * Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg/day
  10. * Patient with a corticosteriod implant (i.e. Ozurdex).
  11. * Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes

Contacts and Locations

Study Locations (Sites)

Briana Parker
Bozeman, Montana, 59718
United States

Collaborators and Investigators

Sponsor: Vance Thompson Vision - MT

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 Date2020-09-14
Study Completion Date2021-08-27

Study Record Updates

Study Start Date2020-09-14
Study Completion Date2021-08-27

Terms related to this study

Additional Relevant MeSH Terms

  • Patient Preference
  • Patient Outcomes
  • Post-Operative Inflammation
  • Grade of Post-Operative Cystoid Macular Edema
  • Rate of Post-Operative Cystoid Macular Edema