The PRIME Study: A Randomized, Controlled, Prospective Study

Vance Thompson Vision - MT

Status and phase: Enrolling; Phase 4

Conditions: Patient Preference; Grade of Post-Operative Cystoid Macular Edema; Post-Operative Inflammation; Rate of Post-Operative Cystoid Macular Edema; Patient Outcomes

Treatments: Drug: Dextenza; Drug: Topical Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT04549935

The PRIME Study

Details and patient eligibility

About

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 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 22 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Group A Dextenza

Active Comparator group

Description:

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.

Treatment:

Drug: Dextenza

Group B Topical Prednisolone

Active Comparator group

Description:

Drug: Topical Prednisolone Standard of care topical drop treatment

Treatment:

Drug: Topical Prednisolone