Cornea and External Disease

Use of Intracanlicular Dexamethasone Insert in Small Incision Lenticule Extraction

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The insert was preferred by more patients compared to topical prednisolone in a randomized, fellow eye-controlled trial.

By Kathleen Jee, MD

The standard postoperative medication regimen following corneal refractive surgery involves the use of topical corticosteroid and antibiotic eye drops multiple times per day. Patient compliance and self-administration issues with the drops are issues that must be considered. Drop regimen complexity is associated with poorer adherence, which increases the risk of inflammation, pain, delayed visual recovery, and patient dissatisfaction.1-4 The use of dropless therapies has been implemented in the setting of cataract surgery to both improve patients’ compliance and their overall experience.5 One such therapy is an FDA-approved, 0.4-mg preservative-free, dexamethasone intracanalicular insert (Dextenza; Ocular Therapeutix). It is designed to be placed in the punctum, where it releases a tapering dose of dexamethasone to the ocular surface for 30 days, and dissolves on its own without the need for removal.6

Evaluating the Insert in SMILE Patients
Small incision lenticule extraction (SMILE), approved for myopia and myopic astigmatism, is a femtosecond laser-based procedure where an intrastromal lenticule is dissected from its anterior and posterior stromal interfaces and removed through a small incision, without use of a flap.7 The use of the Dextenza insert has not previously been described in the setting of SMILE.

A prospective, randomized, fellow eye-controlled trial was conducted to compare postoperative pain, anterior chamber inflammation, and corticosteroid preference in 20 patients undergoing same-day, bilateral SMILE.8 One eye of each patient was randomized to the insert placed in the inferior canaliculus immediately postoperatively, and the fellow eye was randomized to topical prednisolone acetate drops tapered over 2 weeks. All eyes received 0.3% ofloxacin drops for one week and preservative-free artificial tears as needed.

Outcomes of the Study
No eyes in either group had any clinically evident anterior chamber cell or flare at any postoperative time point (day 1, week 1, month 1, month 3), an expected finding as postoperative intraocular inflammation rarely occurs after SMILE. Pain occasionally occurs after SMILE, although it is typically mild in nature. Mean pain scores (0–10 by subjective report) were consistently low (<1) for each group, and incidence of any pain was statistically similar at all postoperative visits. At 3 months, the majority of patients (52.9%) preferred the insert compared to 17.6% for the drops. About one-third of patients had no preference.

Visual outcomes were comparable between treatment groups in this study, with 91% of eyes achieving uncorrected distance visual acuity of 20/25 or better. No eyes lost any lines of corrected distance visual acuity.

The Dextenza insert is an option refractive surgeons may consider for use with SMILE patients, especially if there are concerns about patient compliance or difficulty administering eye drops. Refractive surgeons will need to consider, however, the cost of the insert, as it will not be reimbursed by insurance.

Caution About IOP Elevation With the Insert
Three eyes out of 20 (15%) with the insert in the study developed intraocular pressure (IOP) elevation (defined as >10 mm Hg from baseline) at the 1-month postoperative visit, which was attributed to steroid response from the insert. Two were moderate (peak IOP 25 and 26 mm Hg), and one was more significant, with IOP peak of 45 mm Hg and corneal stromal haze with reduced visual acuity. Two of the eyes received a brief course of topical IOP-lowering therapy. IOP in all three eyes normalized within 1 week, and there was no long-lasting visual impact. No IOP elevations were documented in the prednisolone group.

In phase 3 studies of Dextenza for control of postoperative inflammation and pain following cataract surgery, IOP elevations were reported in 4.4–7.4% of dexamethasone eyes.9,10 It is important to note that the insert will release dexamethasone over a longer period of time (1 month) compared to the standard time SMILE patients use corticosteroid drops (1-2 weeks). Future applications of the insert in conjunction with SMILE could decrease the dose to reduce steroid response.

Refractive surgeons may consider the dexamethasone intracanalicular insert as an alternative to topical corticosteroid drops in the postoperative period. The dexamethasone insert can eliminate the risk of nonadherence with topical steroid therapy and simplify the postoperative drop regimen. However, users must balance the benefit of improved patient compliance and convenience with the slight risk of a short-term steroid response, and from a practical standpoint, consider the cost of the insert.

Kathleen Jee, MD is a refractive surgeon at Cleveland Eye Clinic, Brecksville, OH. Contact: [email protected]


  1. Hermann MM, Ustundag C, Diestelhorst M. Electronic compliance monitoring of topical treatment after ophthalmic surgery. Int Ophthalmol. 2010;30(4):385–390. doi:10.1007/s10792-010-9362-3
  2. Tsai JC. A comprehensive perspective on patient adherence to topical glaucoma therapy. Ophthalmology. 2009;116(11 Suppl):S30–S36. doi:10.1016/j.ophtha.2009.06.024
  3. Sleath B, Carpenter DM, Blalock SJ, et al. Applying the resources and supports in self-management framework to examine ophthalmologist-patient communication and glaucoma medication adherence. Health Educ Res. 2015;30(5):693–705. doi:10.1093/her/cyv034
  4. Newman-Casey PA, Robin AL, Blachley T, et al. The most common barriers to glaucoma medication adherence: a cross-sectional survey. Ophthalmology. 2015;122(7):1308–1316. doi:10.1016/j.ophtha.2015.03.026
  5. Assil KK, Greenwood MD, Gibson A. Dropless cataract surgery: modernizing perioperative medical therapy to improve outcomes and patient satisfaction. Curr Opin OphthalmoL. 2021;32 Suppl 1:S1-S12. doi: 10.1097/ICU.0000000000000708.
  6. Ocular Therapeutix announces FDA approval of Supplemental New Drug Application (sNDA) for DEXTENZA (0.4 dexamethasone intracanalicular insert for ophthalmic use) for the treatment of ocular inflammation following ophthalmic surgery. June 21, 2019. https://tinyurl.com/bddptekw. Accessed March 10, 2023.
  7. Reinstein DZ, Archer TJ, Gobbe M. Small incision lenticule extraction (SMILE) history, fundamentals of a new refractive surgery technique and clinical outcomes. Eye Vis. 2014;1(1):3. doi:10.1186/s40662-014-0003-1
  8. Jee KJ, Ling J, Bafna S, et al. Prospective, randomized, fellow eye-controlled study of postoperative pain and inflammation control with an intracanalicular dexamethasone 0.4 mg ophthalmic insert following small incision lenticule extraction. Clin Ophthalmol. 2022;16:3895-3904. doi: 10.2147/OPTH.S390815. eCollection 2022.
  9. Walters T, Bafna S, Vold S, et al. Efficacy and safety of sustained release dexamethasone for the treatment of ocular pain and inflammation after cataract surgery: results from two phase 3 studies. J Clin Exp Ophthalmol. 2016;7:1-11. doi:10.4172/2155-9570.1000572
  10. Tyson SL, Bafna S, Gira JP, et al. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019;45(2):204-212. doi:10.1016/j.jcrs.2018.09.023


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