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
23
Ophthalmic Intracanalicular Insert
Grene Vision Group
Wichita, Kansas, United States
Grene Vision Group
Wichita, Kansas, United States
Anterior Chamber Cells
As measured by summed ocular inflammation score (0-4 with 4 meaning a worse outcome)
Time frame: Assessed on Day 7
Ocular Pain
As measured by ocular pain assessment numerical grading scale (0-10 with 10 meaning a worse outcome)
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 with 10 meaning a worse outcome)
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 with 4 meaning a worse outcome)
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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