In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery (Prepare)

Vance Thompson Vision

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Drug: Topical prednisolone acetate; Drug: Dextenza 0.4Mg Ophthalmic Insert

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05023304

The Prepare Study

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Group A Dextenza

Experimental group

Description:

Randomized to dexamethasone ophthalmic insert 0.4mg placed prior to cataract surgery, on the day of surgery.

Treatment:

Drug: Dextenza 0.4Mg Ophthalmic Insert

Group B Topical Prednisolone

Active Comparator group

Description:

Randomized to topical prednisolone acetate 1% four times per day for one week, three times per day for one week, two times per day for one week, and one time per day for one week starting after 4 hours after surgery.

Treatment:

Drug: Topical prednisolone acetate