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

Vance Thompson Vision

Status and phase: Completed; Phase 4

Conditions: Refractive Surgery

Treatments: Drug: Topical Prednisolone; Drug: Dextenza 0.4Mg Ophthalmic Insert

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04396990

The RESTORE Study

Details and patient eligibility

About

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.

Full 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, BID 1 week following bilateral PRK surgery. All eyes will receive topical moxifloxacin QID for one week. Moxifloxacin in used post-op regardless of the research. Post-operative evaluations to be performed on Day 3 and Day 4, Month 1, and Month 3. Phone call survey to be performed on Week 2.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Group A Dextenza

Experimental group

Description:

Will receive Dextenza post-operative

Treatment:

Drug: Dextenza 0.4Mg Ophthalmic Insert

Group B Topical Prednisolone

Active Comparator group

Description:

Will receive standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week

Treatment:

Drug: Topical Prednisolone