In this study, the investigators are comparing dexamethasone ophthalmic insert (DEXTENZA®) to the current standard of care, prednisolone acetate 1% eye drops, in a glaucoma population receiving both cataract and minimally-invasive glaucoma surgery (MIGS). DEXTENZA® and prednisolone acetate 1% drops are both steroids used to control inflammation after eye surgery. DEXTENZA®'s method of delivery differs by offering a sustained release of steroid that does not necessitate postoperative anti-inflammatory eye drops. The investigators hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation following concomitant cataract-MIGS in a glaucoma population. The investigators also hypothesize that DEXTENZA® will be preferred by patients over prednisolone acetate 1% drops.
Glaucoma and cataract surgery patients face an outsize postoperative burden. In addition to taking frequent anti-inflammatory eye drops, they often continue their glaucoma medications. This can cause patient confusion and nonadherence, potentially leading to poor healing, slower recovery period, and/or cystoid macular edema. DEXTENZA®, as a sustained release anti-inflammatory insert, could help preclude adherence difficulties and increase comfort by reducing eye drop load. However, glaucoma surgeons may hesitate to adopt DEXTENZA® due to concerns regarding safety with respect to elevated intraocular pressure. This prospective study will address those concerns directly, providing timely and high-quality clinical evidence comparing DEXTENZA® to standard-of-care steroid eye drops. For physicians and patients, the results of this study will prove immediately useful for therapeutic decision-making.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.
Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.
The New York Eye Surgery Center
The Bronx, New York, United States
Change in Intraocular Pressure (IOP) at 1 and 3 Months
Using quantitative IOP readings to compare ocular safety between arms. Since the outcome examined was a "change," baseline, month 1 postop, and month 3 postop data were used in the calculations. 1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value
Time frame: 1 month postop, 3 months postop
Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months
Using quantitative BCVA measurements, as determined by ETDRS chart at 4 meters, to compare ocular safety and effectiveness between arms. Since the outcome examined was a "change," baseline, month 1 postop, and month 3 postop data were used in the calculations. 1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value
Time frame: 1 month postop, 3 months postop
Difference in Eyes With Adverse Events Between Groups
Using the average number of eyes with adverse events that occur in each arm to compare safety between arms through 3 months of postoperative follow-up
Time frame: Up to 3 months postop
Difference in Number of Glaucoma Medications at 3 Months
Using the average number of glaucoma medications added or subtracted to each arm to compare safety between arms. These calculations were performed by subtracting the baseline glaucoma medications from the glaucoma medications at month 3.
Time frame: 3 months postop
Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops
Recording the percentage of eyes in the DEXTENZA® arm that require anti-inflammatory rescue with supplemental ocular steroid. This will provide insight into anti-inflammatory effectiveness of DEXTENZA®
Time frame: Up to 3 months postop
Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT)
Using the number of CME cases in each arm, as visualized by OCT, to compare safety and effectiveness between arms
Time frame: 3 months postop
Difference in Ocular Comfort Index (OCI) Score at 1 Month
Using the Ocular Comfort Index survey to compare patients' self-reported ocular comfort between arms, providing insight into drug effectiveness. The minimum score is 0 and the maximum score is 100, with 100 indicating the most ocular irritation and discomfort and 0 indicating the least ocular irritation and discomfort
Time frame: 1 month postop
Difference in Ocular Comfort Index (OCI) Score at 3 Months
Using the Ocular Comfort Index survey to compare patients' self-reported ocular comfort between arms, providing insight into drug effectiveness. The minimum score is 0 and the maximum score is 100, with 100 indicating the most ocular irritation and discomfort and 0 indicating the least ocular irritation and discomfort
Time frame: 3 months postop
Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month
Comparing the number of eyes with complete AC clearance of inflammatory cells, as determined by slit lamp exam, between arms to evaluate drug effectiveness
Time frame: 1 month postop
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