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.

Keywords: cystoid macular edema; patient preference; punctal plug; steroid; visual acuity.

Figure 1

Patient preference for intracanalicular insert or dexamethasone topical drops assessed using the comparison of ophthalmic medications for tolerability (COMTOL) questionnaire.

Figure 2

Level of satisfaction with preferred treatment method as reported by the comparison of ophthalmic medications for tolerability (COMTOL) questionnaire.

Figure 3

Average side effect frequency; 1–7: I did not have the symptom, rarely, a few times, often, usually, almost always, always.

Figure 4

Uncorrected visual acuity, logarithm of the minimum angle of resolution (LogMAR), as a function of days after surgery.