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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
Standard of care topical drop treatment
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Patient Preference
Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire.
Time frame: Through Month 1 (Day 28 +/- 3 days)
Percentage of Eyes Epithelialized at Day 3
The percentage of eyes with fully healed epithelium at post-op day 3
Time frame: Post-Operative Day 3
Percentage of Eyes Fully Epithelialized at Day 4 Postoperative
The percentage of eyes with fully healed epithelium at day 4 post-operative
Time frame: Postoperative Day 4
Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid)
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.
Time frame: Day 3
SPEED Questionnaire Results at Baseline and Postoperative 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.
Time frame: Pre-op Visit and Month 1 (Day 28)
Uncorrected Distance Visual Acuity
measured using the ETDRS acuity chart at 4 meters recorded in logMAR.
Time frame: Month 1 and Month 3.
Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative
Best-corrected distance visual acuity measured using ETDRS acuity chart at 4 meters, recorded in logMAR notation
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Time frame: Month 1 and Month 3