The PRIME Study: A Randomized, Controlled, Prospective Study

Phase 4

Recruiting

• Conditions: Patient Preference; Grade of Post-Operative Cystoid Macular Edema; Rate of Post-Operative Cystoid Macular Edema; Patient Outcomes; Post-Operative Inflammation
• Interventions: Drug: Topical Prednisolone; Drug: Dextenza

• Registration Number: NCT04549935
• Lead Sponsor: Vance Thompson Vision - MT

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-31
• Study Start: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Last Update Submitted: 2020-09-14
• Study First Posted: 2020-09-16
• Last Update Posted: 2020-09-16
• Primary Completion: 2021-08-27
• Study Completion: 2021-08-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B Topical Prednisolone	Topical Prednisolone	Drug: Topical Prednisolone Standard of care topical drop treatment
Group A Dextenza	Dextenza	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.

Primary Outcome Measures

Name	Time	Method
Patient Preference	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 Outcome Measures

Name	Time	Method
Uncorrected Visual Acuity	Through Month 1	measured by ETDRS chart a 4m
Best Corrected Visual Acuity	Through Month 1	measured by ETDRS chart a 4m
Mean pain score per eye (Group A vs Group B)	Through Month 1	Measured by Visual Analog Scale (0-10, 10 being the worst outcome)
Incidence of post-operative corneal haze	Through Month 1	measured by OCT (Optical Coherence Tomography)
Anterior chamber cell count	Through Month 1	measured by SUN Working Group Grading Scheme
Grade of post-operative corneal haze	Through Month 1	measured by OCT (Optical Coherence Tomography)
Percentage of eyes that have CME (Cystoid macular edema) post-operatively	Through Month 1	Measured by OCT (Optical Coherence Tomography )

Trial Locations

Locations (1)

Briana Parker; 🇺🇸 Bozeman, Montana, United States