A recent real-world registry analysis took a closer look at how the intracanalicular dexamethasone insert stacks up against traditional drops in managing inflammation and pain after cataract surgery.
First, let’s get some background on this topic.
Postoperative inflammation is a predictable consequence of cataract surgery typically managed with topical corticosteroids such as prednisolone or loteprednol.
And while these agents are still the go-to for managing inflammation and pain after cataract surgery, they’re not exactly effortless.
Case in point?
The heavy reliance on patient compliance can often lead to missed doses, improper administration, and complex tapering schedules that affect outcomes.
- Some formulations can also irritate the ocular surface due to preservatives.
- And there’s also the issue of intraocular pressure (IOP) rising in certain patients (although this risk varies depending on the agent and duration of use.)
Taken together, these issues highlight a gap between clinical efficacy and real-world usability, especially in older populations who may already be managing multiple medications.
As such: There’s been growing interest in options—such as the intracanalicular dexamethasone insert—to take some of that burden off patients without sacrificing effectiveness.
So how exactly does the dexamethasone insert come in?
The intracanalicular dexamethasone insert (Dextenza, Ocular Therapeutix) was designed to simplify the postop process by delivering a steady, preservative-free dose of steroid over about 30 days.
What to know: The insert is FDA-approved for treating postoperative inflammation and pain as well as ocular itching tied to allergic conjunctivitis.
How it works: The insert is placed in the canaliculus, where it slowly releases medication over time so patients don’t have to manage a drop schedule.
- This takes adherence out of the equation and avoids repeated exposure to preservatives altogether.
And the clinical data supports its use?
Clinical trials have shown the insert works, but like most treatments, performance in real-world settings can look different once it’s used across a broader mix of patients and everyday practice conditions.
Which brings us to this real-world analysis.
Indeed. The study pulled data from the American Academy of Ophthalmology’s (AAO) Intelligent Research in Sight (IRIS) Registry, one of the largest databases in the United States that compiles de-identified electronic health record (EHR) data from eye care practices across the country.
- And in this analysis: A clearer picture could be obtained on how treatments actually hold up in everyday practice, where factors like comorbidities, provider preferences, and patient variability all come into play.
Instead of a controlled trial setting, the focus here was on safety-related outcomes and patient characteristics across a much larger, more typical patient population.
Noted. So who was included in the study?
The analysis included 10,313 eyes treated with the dexamethasone insert and a control group of 425,098 eyes that did not receive the insert.
- These cases were drawn from a larger population of approximately 3.7 million eyes that underwent cataract surgery during the study period.
Treated eyes were defined as those receiving the insert within two days before or up to seven days after surgery. The control group was assumed to have received standard topical corticosteroid therapy, reflecting typical clinical practice patterns.
So what did the researchers actually find?
Overall, the two groups looked similar in terms of outcomes. Postoperative inflammation, corneal edema, and lacrimal disorders were all uncommon and showed up at comparable rates in both cohorts.
The same held true for cystoid macular edema and epiphora—both were low across the board, with no meaningful differences between the insert and standard drop therapy.
What this suggests: The dexamethasone insert holds its own against traditional topical steroids when it comes to controlling postoperative inflammation in real-world settings.
How did safety outcomes and inflammation compare?
IOP changes were comparable between the insert and control groups, including the incidence of pressure elevations of 10 mmHg or greater within the first postoperative month.
Notably, IOP increases appeared to occur early in both groups, suggesting they were more likely related to the surgical procedure itself rather than a delayed steroid response.
In other words: The similar safety profile across both groups supports the idea that sustained-release steroid delivery does not introduce additional risk compared with standard topical therapy.
What stood out about real-world use patterns?
One notable finding was that eyes with a history of ocular surface disease (OSD) were more likely to receive the dexamethasone insert.
This suggests that clinicians may already be selectively using the insert in patients who are less ideal candidates for topical drops, such as those with dry eye or concerns about adherence.
Additionally, approximately 25% of eyes in both groups had preexisting glaucoma, indicating that use of the insert was not limited to low-risk patients and reflects real-world prescribing behavior.
What limitations should be kept in mind?
Considering the nature of this retrospective registry analysis, the following is worth keeping in mind when interpreting the results:
For one: Treatment wasn’t randomized, and the control group was assumed (rather than confirmed) to be using topical corticosteroids.
- This leaves some room for variation in how those patients were actually treated.
Also: Registry data typically rely on accurate coding and documentation—and don’t always capture the finer details such as exact dosing schedules, how well patients adhered to treatment, or subtle differences in disease severity.
What does this mean for clinical practice?
The results position the dexamethasone insert as a practical alternative to topical corticosteroids for managing postoperative inflammation after cataract surgery.
While not necessarily superior, the insert's drop-free delivery offers a practical alternative that reduces reliance on patient-administered drops—potentially making a real difference for patients:
- Who struggle with adherence
- With underlying ocular surface disease
- Already managing multiple medications
For clinicians, the decision may come down to convenience, patient preference, and individual risk factors rather than efficacy alone.