In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

Completed · Phase 4

Conditions studied: Cataract

In brief

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.

Key facts

Study ID: NCT05023304
Run by: Vance Thompson Vision
People needed: 30
Starts: 2021-08-23
Expected to finish: 2022-10-01
Last updated by the study team: 2025-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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).

Where it is running

Vance Thompson Vision — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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