A Randomized, Controlled, Prospective Study of the Effectiveness and Safety of an Intracanalicular Dexamethasone Ophthalmic Insert (0.4 Mg) for the Treatment of Post-Operative Inflammation in Patients Undergoing Refractive Lens Exchange (RLE)

Abstract

Purpose: To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4 mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral RLE surgery. Methods: This is a prospective, open-label, interventional, randomized, controlled study in 20 subjects who underwent bilateral RLE. Each patient served as their own control with one eye randomized to the intracanalicular insert (Group A) placed at the time of surgery and the contralateral randomized to topical corticosteroid drops (Group B). All eyes received intracameral moxifloxacin at the time of surgery, and post-operatively, topical moxifloxacin QID for one week and topical NSAID daily for four weeks. Post-operative evaluations were performed on Day 1, Week 1, and Week 4-8. Results: Twenty patients participated. At 4-8 weeks post-operation, 90% of patients evaluated with the COMTOL questionnaire preferred the intracanalicular insert while 10% preferred the topical steroid. Comparative analysis using the visual analog scale showed no difference in pain between the study and control group. No statistical difference was shown in post-operative corneal staining, anterior chamber cell count, anterior chamber flare or intraocular pressure. Mean LogMAR UCVA at 4-8 weeks post-operation was 0.06 (± 0.230) in the study group and 0.065 (± 0.241) in the control group, which was not statistically or clinically different (p > 0.05). Conclusion:Patients undergoing bilateral RLE expressed a strong preference towards the use of an intracanalicular insert over a topical steroid for post-operative steroid treatment. There was no clinically or statistically significant difference in outcomes, including rate of cystoid macular edema, visual acuity and elevation of intraocular pressure. National Clinical Trial Number: 04549935.

Early Real-World Physician Experience with an Intracanalicular Dexamethasone Insert

“… 19 , 20 , 22 In addition to cataract patients, physicians most often indicated that on-label use of DEX could benefit patients undergoing pterygium surgery, corneal surgery, and refractive procedures (which have been studied in LASIK and refractive lens exchange) ( Table 2 ). 23 , 24 One of the greatest perceived values of DEX according to physicians was its ability to treat the ocular surface with a preservative-free formulation. As might be expected based on the high prevalence of dry eye in the United States, 25 , 26 dry eye was the most common comorbidity of the cataract surgery patients in our study.…”

“… 2–4 , 12 They may improve clinic efficiency by decreasing the need for filling a prescription, which is time-efficient for both healthcare providers as well as patients. 24 …”

“…[2][3][4]12 They may improve clinic efficiency by decreasing the need for filling a prescription, which is timeefficient for both healthcare providers as well as patients. 24 As DEX is physician-administered, it eliminates the potential for improper drop installation techniques, including missing the eye, and bottle tip contamination due to contact with ocular surface, eyelid or lashes. 27,30 Their use thus shifts the reliance of administration from patient to physician reducing risks associated with improper instillation technique, and eliminating non-adherence, resulting in better efficacy, and safety outcomes.…”

Thermal Pulsation with or without Dexamethasone Intracanalicular Insert for Meibomian Gland Dysfunction: A Prospective, Masked Trial

“… 11–13 It is approved in the United States for the control of pain and inflammation following ocular surgery, 14 and its role in postoperative care has been demonstrated following cataract extraction in adults 11 , 12 , 46–48 and children, 49 pars plana vitrectomy, 20 as well as refractive surgical procedures. 18 , 19 , 50 Phase 2 and 3 trials have also evaluated DEX for chronic inflammation associated with allergic conjunctivitis and reported short-term improvements in itching and conjunctival hyperemia. 51–53 Given the role of inflammation in MGD, we hypothesized in this study that DEX may provide additional therapeutic benefit when combined with thermal pulsation therapy for MGD.…”

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

“…No formal power analysis was conducted, and the sample size was set at 40 eyes based on the sample size used in several similar prior studies. [18][19][20] Chi-square tests were used to compare proportions and t-tests to compare means. The level of significance was set at 0.05.…”