Status:
COMPLETED
The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study
Lead Sponsor:
Vance Thompson Vision
Collaborating Sponsors:
Ocular Therapeutix, Inc.
Conditions:
Refractive Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, BI...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04396990
Start Date
June 8 2020
End Date
September 28 2020
Last Update
July 30 2024
Active Locations (1)
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1
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108