The PRIME Study: A Randomized, Controlled, Prospective Study

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.

Conditions

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

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Study Overview

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Study Details

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.

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)

The PRIME Study: A Randomized, Controlled, Prospective Study

Condition
Patient Preference
Intervention / Treatment

-

Contacts and Locations

Bozeman

Briana Parker, Bozeman, Montana, United States, 59718

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

22 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Vance Thompson Vision - MT,

Study Record Dates

2021-08-27