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Recruiting NCT04549935

The PRIME Study: A Randomized, Controlled, Prospective Study

Phase IV Interventional Patient Preference Patient Outcomes Post-Operative Inflammation Grade of Post-Operative Cystoid Macular Edema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dextenza, Topical Prednisolone.
Who it may be relevant to
Registry conditions: Patient Preference, Patient Outcomes, Post-Operative Inflammation, Grade of Post-Operative Cystoid Macular Edema. Basic parameters: 22 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

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.

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

Primary outcome measures

  • Patient Preference [Time frame: Through Month 1]
Secondary outcome measures (7)
  • Percentage of eyes that have CME (Cystoid macular edema) post-operatively [Time frame: Through Month 1]
  • Mean pain score per eye (Group A vs Group B) [Time frame: Through Month 1]
  • Incidence of post-operative corneal haze [Time frame: Through Month 1]
  • Grade of post-operative corneal haze [Time frame: Through Month 1]
  • Anterior chamber cell count [Time frame: Through Month 1]
  • Uncorrected Visual Acuity [Time frame: Through Month 1]
  • Best Corrected Visual Acuity [Time frame: Through Month 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Briana Parker — Bozeman

Identifiers

NCT: NCT04549935 · The PRIME Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗