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

Phase 4

Completed

Interventions: Drug: Dextenza 0.4Mg Ophthalmic Insert
Drug: Topical Prednisolone

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 surgery.

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, 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Group A Dextenza	Dextenza 0.4Mg Ophthalmic Insert	Will receive Dextenza post-operative
Group B Topical Prednisolone	Topical Prednisolone	Will receive standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week

Primary Outcome Measures

Name	Time	Method
Patient Preference	Through Month 1 (Day 28 +/- 3 days)	Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire.

Secondary Outcome Measures

Name	Time	Method
Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid)	Day 3	Pain score as measured by the Numerical Rating Scale (NRS) at day 3 post-operative. The rating scale is from 0-10 with 0 being no pain and 10 being severe pain.
Percentage of Eyes Fully Epithelialized at Day 4 Postoperative	Postoperative Day 4	The percentage of eyes with fully healed epithelium at day 4 post-operative
SPEED Questionnaire Results at Baseline and Postoperative Day 28	Pre-op Visit and Month 1 (Day 28)	Patient evaluation of eye dryness measured by a modified SPEED questionnaire with a results recorded 0-28 with 28 being the most severe.
Percentage of Eyes Epithelialized at Day 3	Post-Operative Day 3	The percentage of eyes with fully healed epithelium at post-op day 3
Uncorrected Distance Visual Acuity	Month 1 and Month 3.	measured using the ETDRS acuity chart at 4 meters recorded in logMAR.
Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative	Month 1 and Month 3	Best-corrected distance visual acuity measured using ETDRS acuity chart at 4 meters, recorded in logMAR notation