In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mitchel Ibach
• Collaborator: Ocular Therapeutix, Inc.
• Treatments: Prednisolone

Criteria

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).