Prepare: In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Group A Dextenza
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Drug: Dextenza 0.4Mg Ophthalmic 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 the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
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Active Comparator: Group B Topical Prednisolone
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Drug: Topical Prednisolone
Standard of care topical drop treatment
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Outcome Measures
Primary Outcome Measures
- Mean anterior chamber cell/flare score [post-op Day 1]
Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)
- Mean anterior chamber cell/flare score [post-op Day 7]
Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)
- Mean anterior chamber cell/flare score [post-op Week 4.]
Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)
- Mean pain score [post-op Day 1]
Mean pain score measured by Visual Analog Score numerical grading scale 0-10
- Mean pain score [post-op Day 7]
Mean pain score measured by Visual Analog Score numerical grading scale 0-10
- Mean pain score [post-op Week 4]
Mean pain score measured by Visual Analog Score numerical grading scale 0-10
- Patient preference [post-op Week 4]
As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire
Secondary Outcome Measures
- Incidence of increased intraocular pressure (IOP) >10mmHg above baseline [postop Day 1]
Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer
- Incidence of increased intraocular pressure (IOP) >10mmHg above baseline [postop Day 7]
Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer
- Incidence of increased intraocular pressure (IOP) >10mmHg above baseline [postop Week 4]
Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer
- Incidence of Cystoid Macular Edema (CME) [post-op Week 4]
Incidence of Cystoid Macular Edema (CME) as measured by optical coherence tomography (OCT)
- Physician Ease of Use [Day 0]
Physician Ease of Use Survey following dexamethasone intracanalicular placement on Surgical Visit
- Eye Drop Burden [post-op Day 7]
Eye Drop Burden Questionnaire numerical grading scale of 1-5
- Eye Drop Burden [post-op Week 4]
Eye Drop Burden Questionnaire numerical grading scale of 1-5
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients 18 years of age or older, undergoing routine, uncomplicated, sequential bilateral cataract surgery.
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Willing and able to comply with clinic visits and study related procedures
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Willing and able to sign the informed consent form
Exclusion Criteria:
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Patients under the age of 18.
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Patients who are pregnant (must be ruled out in women of childbearing age with pregnancy test).
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Active infectious ocular or systemic disease.
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Patients with active infectious ocular or extraocular disease.
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Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
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Patients with known hypersensitivity to Dexamethasone.
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Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
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Patients with proliferative diabetic retinopathy or uncontrolled diabetes as deemed by an A1C > 10.0.
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Patients with a history of ocular inflammation or macular edema.
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Patients with a pre-existing epiretinal membrane (ERM)
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Patients with allergy or inability to receive intracameral antibiotic.
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Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day The PREPARE Study (V1) February, 2021 Page 27 CONFIDENTIAL
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Patients with a corticosteroid implant (i.e. Ozurdex).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mitchel Ibach
- Ocular Therapeutix, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- The Prepare Study