The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study
Completed · Phase 4
Conditions studied: Refractive Surgery
In brief
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.
Key facts
- Study ID
- NCT04396990
- Run by
- Vance Thompson Vision
- People needed
- 20
- Starts
- 2020-06-08
- Expected to finish
- 2020-09-28
- Last updated by the study team
- 2024-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Vance Thompson Vision — Sioux Falls, South Dakota, United States
Full record on ClinicalTrials.gov
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