Randomized, controlled treatment with an intracanalicular dexamethasone (0.4mg) insert following cataract surgery with intraocular lens implant (IOL) combined with minimally invasive glaucoma surgery (MIGS), specifically iStent, iStent inject or KDB in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHTN)
To determine treatment and patient reported outcomes, following cataract surgery with intraocular lens implant in conjunction with minimally invasive glaucoma surgery (MIGS) more specifically iStent, iStent inject or KDB with an intracanalicular dexamethasone (0.4 mg) insert, inserted four days (+/- 1 day) prior to surgery as compared to insertion on day of surgery. Patients with either primary open angle glaucoma (POAG) or ocular hypertension (OHTN) requiring cataract surgery with IOL implant, will be separated into two groups. Group 1: intracanalicular dexamethasone (0.4 mg) insertion four days (+/- 1 day) prior to cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery) Group 2: intracanalicular dexamethasone (0.4 mg) insertion on the day of cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery or inserted the day of surgery.
Wolstan and Goldberg Eye Associates
Torrance, California, United States
Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery
Primary: Will receive the insert four days (+/- 1 day) prior to surgery. Each enrolled subject will be required to complete seven scheduled visits over the course of the study period: Baseline, insertion visit, operative visit, Day 1, 7, 30, and a 14 \& 45-day phone call. Absence of cells in anterior chamber at day 7 as measured by: Summed Ocular Inflammation Score (0-4) Absence of cell to be defined as a grade of (0-0.5) Absence of pain at Day 7 (score of 0) as measured by ocular pain assessment numerical grading scale 0-10 Mean change in BCVA from baseline (Day 7,30) Mean change in OCT from baseline (Day 30) Physician ease of intracanalicular insertion evaluation as measured by physician questionnaire Incidence and severity of ocular and systemic AE's (Day 1,7,14,30,45)
Time frame: four days (+/- 1 day) prior to surgery with visits scheduled at day 1, day 7, day 14, day 30, and day 45.
Intracanalicular Dexamethasone, 0.4 mg insertion on day of surgery.
Secondary: Will receive the insert on the day of surgery. Each enrolled study subject will be required to complete six scheduled visits over the course of the study period: Screening visit, operative/insertion visit, Day 1, 7, 30, and a 14 \& 45 day phone call. Measuring cell, pain and flare at (Day 1,30) Absence of cell to be defined as a grade of (0-0.5) Absence of flare to be defined as a grade of (0-1) Determining if call backs have decreased at the clinic with study patients
Time frame: insertion on day of surgery with scheduled visits on day 1, day 7, day 14, day 30, and day 45.
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