Comparison of the Postoperative Use of Dextenza vs a Standard Regimen After PRK

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Naval Refractive Surgery Center proposes a prospective, single-site, randomized, non-FDA regulated clinical trial with bilateral commercial treatment for for PRK. Subjects will be randomized to receive one of two postoperative steroid regimens: Dextenza (a dexamethasone ophthalmic insert) or standard of care topical Fluorometholone. Subjects will be followed for 3 months after surgery. Investigators will use objective and subjective measures to assess potential differences in postoperative healing and pain.

This study will not be FDA-regulated. All study surgeries will be standard of care, with the exception of the addition of the Dextenza insert after the PRK procedure among subjects randomized to the Dextenza group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Navy Medical Center San Diego
• Treatments: Fluorometholone

Criteria

Inclusion Criteria:

1. Male and female subjects 18 years of age and older, either active duty or dependents, who are eligible for care;

2. Myopia with manifest refractions ranging from 0.00 D to -8.00 D MRSE, with astigmatism ranging from 0.00 to -3.00 D CYL.

3. A stable refraction for the past year, as demonstrated by change in Sphere of ≤ 0.50 D and/or change in Cylinder of ≤ 0.50 D in the eyes to be treated;

4. A difference between cycloplegic and manifest refractions of

≤ 0.75 D MRSE in both eye(s);

5. BSCVA at least 20/20 in the treated eyes;

6. Discontinue use of contact lenses for at least 4 weeks (for hard lenses) or 2 weeks (for soft lenses) prior to the preoperative examination, and through entire study. The subject shall not be considered a contact lens wearer if they are not wearing hard contact lenses for 4 weeks or soft contact lenses for 2 weeks;

7. Central corneal thickness of at least 500 microns in the both eye(s);

8. Willing and able to return for scheduled follow-up examinations;

9. Able to provide written informed consent and follow study instructions in English.

10. Permission of the Commanding Officer for active duty subjects to receive refractive surgery and participate in the study.

11. Qualifies for treatment on all study lasers within FDA-approved parameters.

Exclusion Criteria:

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