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:

• punctal plug
• steroid
• visual acuity
• cystoid macular edema
• patient preference

Data Sharing Statement

Able to provide de-identified conglomerate data upon request to Jacob Larsen.

Acknowledgments

Authors acknowledge support for this investigator initiator trial from Ocular Therapeutix.

Disclosure

The authors report no conflicts of interest for this work.