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

Refractive Surgery Clinical Trial

Official title:
A Randomized, Controlled, Masked (Reading Center) Prospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the Treatment of Post-operative Inflammation and Pain in Patients Who Have Undergone PhotoREfractive Keratectomy (PRK)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04396990
Study type Observational
Source Vance Thompson Vision
Contact
Status Completed
Phase
Start date June 8, 2020
Completion date September 28, 2020
View Details
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