To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.
This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op. There will be approximately 50 eyes with two groups: Group 1 (up to 10 eyes) will receive the insert in the lower punctum on the day of surgery in the OR. Group 2 (up to 40 eyes) will receive the insert in the lower punctum on the day after surgery in the HOPD. Each subject's participation is expected to last for approximately 1 month and will be required to complete five scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 7 and Day 30.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Dextenza
Anterior Chamber Cells
As measured by summed ocular inflammation score (0-4)
Time frame: Assessed on Day 7
Ocular Pain
As measured by ocular pain assessment numerical grading scale (0-10)
Time frame: Assessed on Day 7
Mean change in BCVA
As measured by snellen VA
Time frame: Assessed on Day -1, Day 7, Day 30
Percentage with complete absence of pain
As measured by ocular pain assessment numerical grading scale (0-10)
Time frame: Assessed on Day -1, Day 1, Day 7, Day 30
Percentage with complete absence of cell
As measured by summed ocular inflammation score (0-4)
Time frame: Assessed on Day -1, Day 1, Day 7, Day 30
Physician ease of insertion and visualization
As measured by physician questionnaire
Time frame: Assessed on Day 1
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