Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery
- Conditions
- GlaucomaCataract
- Interventions
- Registration Number
- NCT04200651
- Lead Sponsor
- The New York Eye Surgery Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
- Cataract surgery candidate and glaucoma present in at least one eye.
- Minimally-invasive glaucoma surgery candidate in that same eye. Defined by having ocular hypertension requiring a medication, OR as by having mild, moderate, or severe glaucoma that is sufficiently stable and appropriate for operation.
- Maintains regular use (daily or more) of systemic or ocular steroids at time of enrollment
- Maintains regular use (daily or more) of systemic or ocular nonsteroidal anti-inflammatory drugs at time of enrollment
- Anterior chamber cells present at time of enrollment
- Recent febrile illness that precludes or delays participation for 3 months
- Pregnancy or lactation
- Known allergy to dexamethasone
- Known allergy to prednisolone
- Treatment with another investigational drug within the last 20 years
- Current recreational drug use
- Preexisting ocular pathology likely to confound the visual acuity or comfort endpoints including but not limited to: severe corneal scarring, ocular surface disease, diabetic retinopathy, or macular edema
- Corneal or retinal procedures (laser or incisional) during the study period and 6 months prior
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prednisolone acetate 1% arm Prednisolone Acetate 1% Oph Susp This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS. DEXTENZA® arm Dexamethasone Ophthalmic Insert This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.
- Primary Outcome Measures
Name Time Method Change in Intraocular Pressure (IOP) at 1 and 3 Months 1 month postop, 3 months postop 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 valueChange in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months 1 month postop, 3 months postop 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 valueDifference in Eyes With Adverse Events Between Groups Up to 3 months postop 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
Difference in Number of Glaucoma Medications at 3 Months 3 months postop 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.
- Secondary Outcome Measures
Name Time Method Difference in Ocular Comfort Index (OCI) Score at 1 Month 1 month postop 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
Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT) 3 months postop Using the number of CME cases in each arm, as visualized by OCT, to compare safety and effectiveness between arms
Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops Up to 3 months postop 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®
Difference in Ocular Comfort Index (OCI) Score at 3 Months 3 months postop 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
Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month 1 month postop Comparing the number of eyes with complete AC clearance of inflammatory cells, as determined by slit lamp exam, between arms to evaluate drug effectiveness
Trial Locations
- Locations (1)
The New York Eye Surgery Center
🇺🇸Bronx, New York, United States