In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

Phase 4

Not yet recruiting

• Conditions: Cataract
• Interventions: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Topical Prednisolone

• Registration Number: NCT05023304
• Lead Sponsor: Mitchel Ibach

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-02
• Study Start: 2021-08-23
• Study First Submitted QC: 2021-08-25
• Last Update Submitted: 2021-08-25
• Study First Posted: 2021-08-26
• Last Update Posted: 2021-08-26
• Primary Completion: 2022-07-27
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A Dextenza	Dextenza 0.4Mg Ophthalmic Insert	-
Group B Topical Prednisolone	Topical Prednisolone	-

Primary Outcome Measures

Name	Time	Method
Patient preference	post-op Week 4	As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire
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 Week 4	Mean pain score measured by Visual Analog Score numerical grading scale 0-10

Secondary Outcome Measures

Name	Time	Method
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)
Eye Drop Burden	post-op Week 4	Eye Drop Burden Questionnaire numerical grading scale of 1-5
Physician Ease of Use	Day 0	Physician Ease of Use Survey following dexamethasone intracanalicular placement on Surgical Visit