Dropless anti-inflammatory strategies after cataract surgery include subconjunctival, sub-Tenon, and intracameral approaches that can potentially lead to concentrating an agent locally or raising intraocular pressure (IOP), as well as the infection risk with injections. Another option, intracanalicular dexamethasone insert has demonstrated inflammation reduction, and a new trial published in the Journal of Cataract & Refractive Surgery offers data supporting this method’s comparable efficacy to topical steroids.
Investigators of the retrospective case series screened 358 patients (358 eyes) who underwent planned phacoemulsification at Penn State Health Eye Center, in Hershey, Pennsylvania. Of the total, 131 received postoperative prednisolone eye drops from January 2018 to November 2019, and 131 opted for an intracanalicular dexamethasone 0.4 mg insert. Participants in both groups were consecutively screened and included only if insurance covered the insert. First-operated eye data was used.
One week after surgery, 46.2% of dexamethasone-treated eyes had a trace or greater amount of anterior chamber cells, compared with 31.9% of those in the topical steroid group (P =.03). However, no statistically significant difference was reported between groups for mean change in IOP, pain, or conjunctival injection. Individuals with diabetes retinopathy in either set also took ketorolac tromethamine 0.5% drops for 1 month. Excluding these eyes, there remained no significant differences in IOP change, pain, or conjunctival injection.
At final follow-up approximately 1 month after surgery, mean IOP was 15.2±3.2 mm Hg for individuals in the insert cohort, and 15.0±4.1 mm Hg in topically-treated patients (P =.74), with no large difference in change from baseline between groups (P =.85). For participants who attended the last visit, 9.2% of eyes with insert and 6.9% receiving topical agents experienced breakthrough inflammation that needed treatment (P =.50).
Post hoc analysis reveals variables associated with breakthrough inflammation include anterior chamber cells (P <.001), conjunctival injection (P =.01), pain (P =.02), and IOP change (P =.03). Demographics or systemic disorders do not correlate to breakthrough inflammation, although trends appeared for individuals with worse baseline visual acuity, diabetes type 1, and autoimmune conditions — indicating need for observation.
“…[P]atients should be advised that they may note an increase of epiphora in the short term while the insert is resorbing,” according to the researchers. “…Most importantly, they should be counseled up front on the signs and symptoms of breakthrough inflammation, which include increased conjunctival hyperemia and photosensitivity.”
Despite more eyes with insert showing anterior chamber cells after 1 week, no significant association with breakthrough inflammation emerged. The investigators speculate this may be because of inadequate post hoc power, risk factors, or simply that the insert is accompanied by a slight increase in cells, but does not evolve. Or, too little medication may be released in the early post-op period for some, necessitating adjunctive therapy.
This trial was not randomized and investigators were unmasked, representing limitations, as well as not enough power to detect more infrequent complications such as endophthalmitis. Also, patients with glaucoma were excluded, so no data was generated for this subgroup.
Disclosures: The study was supported by Ocular Therapeutix, Inc. as an investigator-initiated trial. A study author has declared affiliations with the medical device and eye care products industries. Please see the original reference for a full list of disclosures.
Lu AQ, Rizk M, O’Rourke T, et al. Safety and efficacy of topical vs intracanalicular corticosteroids for the prevention of postoperative inflammation after cataract surgery. J Cataract Refract Surg. 2022;48(11):1242–1247. doi:10.1097/j.jcrs.0000000000000963