Clinical trial NCT04549935: The PRIME Study: A Randomized, Controlled, Prospective Study
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Patient Preference
Patient Outcomes
Post-Operative Inflammation
Grade of Post-Operative Cystoid Macular Edema
Rate of Post-Operative Cystoid Macular Edema
Lead sponsor: Vance Thompson Vision - MT
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Patient Preference
timeFrame: Through Month 1
Secondary outcomes:
measure: Percentage of eyes that have CME (Cystoid macular edema) post-operatively
timeFrame: Through Month 1
measure: Mean pain score per eye (Group A vs Group B)
timeFrame: Through Month 1
measure: Incidence of post-operative corneal haze
timeFrame: Through Month 1
measure: Grade of post-operative corneal haze
timeFrame: Through Month 1
measure: Anterior chamber cell count
timeFrame: Through Month 1
measure: Uncorrected Visual Acuity
timeFrame: Through Month 1
measure: Best Corrected Visual Acuity
timeFrame: Through Month 1
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Briana Parker
state: Montana
Study officials:
References: