In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

Study Overview
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Brief Summary
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To evaluate the clinical outcomes with optometrist pre-surgical insertion of DEXTENZA in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy.

Official Title
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In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

Conditions
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Cataract

Intervention / Treatment
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* Drug: Dextenza 0.4Mg Ophthalmic Insert
* Drug: Topical Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older, undergoing routine, uncomplicated, sequential bilateral cataract surgery. 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 18. Patients who are pregnant (must be ruled out in women of childbearing age with pregnancy test). Active infectious ocular or systemic disease. Patients with active infectious ocular or extraocular disease. Patients actively treated with local or systemic immunosuppression including systemic corticosteroids. Patients with known hypersensitivity to Dexamethasone. Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator. Patients with proliferative diabetic retinopathy or uncontrolled diabetes as deemed by an A1C > 10.0. Patients with a history of ocular inflammation or macular edema. Patients with a pre-existing epiretinal membrane (ERM) Patients with allergy or inability to receive intracameral antibiotic. Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day The PREPARE Study (V1) February, 2021 Page 27 CONFIDENTIAL Patients with a corticosteroid implant (i.e. Ozurdex).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A Dextenza<br> | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* 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 the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.<br>|
| Active Comparator: Group B Topical Prednisolone<br> | Drug: Topical Prednisolone<br>* Standard of care topical drop treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean anterior chamber cell/flare score | Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme) | post-op Day 1 | 
| Mean anterior chamber cell/flare score | Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme) | post-op Day 7 | 
| Mean anterior chamber cell/flare score | Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme) | post-op Week 4. | 
| Mean pain score | Mean pain score measured by Visual Analog Score numerical grading scale 0-10 | post-op Day 1 | 
| Mean pain score | Mean pain score measured by Visual Analog Score numerical grading scale 0-10 | post-op Day 7 | 
| Mean pain score | Mean pain score measured by Visual Analog Score numerical grading scale 0-10 | post-op Week 4 | 
| Patient preference | As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire | post-op Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of increased intraocular pressure (IOP) >10mmHg above baseline | Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer | postop Day 1 | 
| Incidence of increased intraocular pressure (IOP) >10mmHg above baseline | Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer | postop Day 7 | 
| Incidence of increased intraocular pressure (IOP) >10mmHg above baseline | Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer | postop Week 4 | 
| Incidence of Cystoid Macular Edema (CME) | Incidence of Cystoid Macular Edema (CME) as measured by optical coherence tomography (OCT) | post-op Week 4 | 
| Physician Ease of Use | Physician Ease of Use Survey following dexamethasone intracanalicular placement on Surgical Visit | Day 0 | 
| Eye Drop Burden | Eye Drop Burden Questionnaire numerical grading scale of 1-5 | post-op Day 7 | 
| Eye Drop Burden | Eye Drop Burden Questionnaire numerical grading scale of 1-5 | post-op Week 4 |