The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study

• Status: Recruiting
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

Summary

To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral PRK surgery.

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

Details

• Lead Sponsor: Vance Thompson Vision
• Collaborator: Ocular Therapeutix, Inc.
• Treatments: Prednisolone

Criteria

Inclusion Criteria:

• Any adult patient who is planned to undergo bilateral PRK 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 child-bearing 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 a history of ocular inflammation or macular edema.

• Patients with allergy or inability to receive intracameral antibiotic.

• Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day

• Patients with a corticosteroid implant (i.e. Ozurdex).

• Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes.

• Patients who do not have 20/20 snellen visual acuity potential pre-operatively.

• MRSE greater than 6 diopters.

• Greater than 2 diopters anisometropia.