The PRIME Study: A Randomized, Controlled, Prospective Study

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: August 27, 2021

Detailed Description

A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.

Interventions

  • Drug: Dextenza
    • Dextenza 0.4mg
  • Drug: Topical Prednisolone
    • Standard of care topical drop treatment

Arms, Groups and Cohorts

  • Active Comparator: Group A Dextenza
    • Drug: Dextenza 0.4mg Opthalmic Insert The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion, The attributes of the insert reduce risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration.
  • Active Comparator: Group B Topical Prednisolone
    • Drug: Topical Prednisolone Standard of care topical drop treatment

Clinical Trial Outcome Measures

Primary Measures

  • Patient Preference
    • Time Frame: Through Month 1
    • As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome)

Secondary Measures

  • Percentage of eyes that have CME (Cystoid macular edema) post-operatively
    • Time Frame: Through Month 1
    • Measured by OCT (Optical Coherence Tomography )
  • Mean pain score per eye (Group A vs Group B)
    • Time Frame: Through Month 1
    • Measured by Visual Analog Scale (0-10, 10 being the worst outcome)
  • Incidence of post-operative corneal haze
    • Time Frame: Through Month 1
    • measured by OCT (Optical Coherence Tomography)
  • Grade of post-operative corneal haze
    • Time Frame: Through Month 1
    • measured by OCT (Optical Coherence Tomography)
  • Anterior chamber cell count
    • Time Frame: Through Month 1
    • measured by SUN Working Group Grading Scheme
  • Uncorrected Visual Acuity
    • Time Frame: Through Month 1
    • measured by ETDRS chart a 4m
  • Best Corrected Visual Acuity
    • Time Frame: Through Month 1
    • measured by ETDRS chart a 4m

Participating in This Clinical Trial

Inclusion Criteria

  • Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

Exclusion Criteria

  • Patients under the age of 22 or above the age of 75
  • Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
  • Patients with active infectious ocular or extraocular disease.
  • Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
  • Paitents with know hypersensitivity to Dexamethasone
  • Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator
  • Patients with a history of ocular inflammation or macular edema
  • Patients with allergy or inability to receive intracameral antibiotic
  • Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg/day
  • Patient with a corticosteriod implant (i.e. Ozurdex).
  • Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes

Gender Eligibility: All

Minimum Age: 22 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Vance Thompson Vision – MT
  • Provider of Information About this Clinical Study
    • Sponsor

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