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

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Vance Thompson Vision
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Updated on 16 February 2024
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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.

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.

Details
Condition Surgical ocular refractive procedure
Age 18years - 100years
Treatment Dextenza 0.4Mg Ophthalmic Insert, Topical Prednisolone
Clinical Study IdentifierNCT04396990
SponsorVance Thompson Vision
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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