Phase 4
N=40
The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study
Refractive Surgery
Bottom Line
View on ClinicalTrials.gov: NCT04396990 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Patient Preference — 14; 4; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dextenza 0.4Mg Ophthalmic Insert (Drug); Topical Prednisolone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vance Thompson Vision
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Preference |
14; 4; 2 | — |
| SECONDARY Percentage of Eyes Epithelialized at Day 3 |
20; 20; 0; 0 | — |
| SECONDARY Percentage of Eyes Fully Epithelialized at Day 4 Postoperative |
19; 20; 1; 0 | — |
| SECONDARY Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid) |
0.9; 0.850 | — |
| SECONDARY SPEED Questionnaire Results at Baseline and Postoperative Day 28 |
3.75; 3.70; 4.00; 4.22 | — |
| SECONDARY Uncorrected Distance Visual Acuity |
0.0005; -0.073; -1.117; -0.153 | — |
| SECONDARY Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative |
-0.051; -0.093; -0.146; -0.167 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04396990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.