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Recruiting

NCT Number: NCT04549935

The PRIME Study: A Randomized, Controlled, Prospective Study

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.

Recruiting

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Key information

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Briana Parker

Bozeman, Montana, 59718, United States

Location status: Recruiting

Location contact

Briana Parker

CONTACT

[email protected]

406-599-5961

Keeley Puls

CONTACT

[email protected]

605 371-7075

Russell Swan, MD

PRINCIPAL_INVESTIGATOR

Seirra Steiner, OD

SUB_INVESTIGATOR

Travis Whitt, OD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dextenza

Drug

Dextenza 0.4mg

Topical Prednisolone

Drug

Standard of care topical drop treatment

Primary outcomes

  1. 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 outcomes

  1. Percentage of eyes that have CME (Cystoid macular edema) post-operatively

    Time frame: Through Month 1

    Measured by OCT (Optical Coherence Tomography )

  2. 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)

  3. Incidence of post-operative corneal haze

    Time frame: Through Month 1

    measured by OCT (Optical Coherence Tomography)

  4. Grade of post-operative corneal haze

    Time frame: Through Month 1

    measured by OCT (Optical Coherence Tomography)

  5. Anterior chamber cell count

    Time frame: Through Month 1

    measured by SUN Working Group Grading Scheme

  6. Uncorrected Visual Acuity

    Time frame: Through Month 1

    measured by ETDRS chart a 4m

  7. Best Corrected Visual Acuity

    Time frame: Through Month 1

    measured by ETDRS chart a 4m

Sponsors and collaborators

Lead sponsor

Vance Thompson Vision - MT

Other

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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