A Randomized, Prospective, Observer-Masked Study Comparing Dropless Treatment Regimen Using Intracanalicular Dexamethasone Insert, Intracameral Ketorolac, and Intracameral Moxifloxacin versus Conventional Topical Therapy to Control Postoperative Pain and Inflammation in Cataract Surgery

Abstract

Purpose

To evaluate clinical efficacy and patient preference for a dropless treatment regimen compared to conventional topical therapy in patients undergoing cataract surgery.

Patients and Methods

In this prospective, contralateral eye study, patients with bilateral cataract were randomized to receive either intracanalicular dexamethasone insert, intracameral phenylephrine 1%/ketorolac 0.3%, and intracameral moxifloxacin (50 µg) (study group) or topical moxifloxacin 0.5%, ketorolac 0.5%, and prednisolone acetate 1.0% QID (control group). The second eye underwent cataract surgery 2 weeks later and was treated with the opposite treatment. All patients were evaluated at Days 1, 7, 14, 28, and 3 months. The primary outcome measure was postoperative ocular pain. Secondary outcomes included summed ocular inflammation score (SOIS; the sum of the mean anterior chamber cells and anterior flare score), the patient preference for medication protocol between the two eyes, and patient out-of-pocket cost of medications. Safety outcome measures included CDVA, intraocular pressure, central retinal thickness (CRT), and the incidence of reported AEs.

Results

The proportion of patients with no pain was similar in both groups at all postoperative visits (p>0.05). No statistically significant difference in SOIS score was observed between the two groups at any visit. A strong majority of the patients (94.7%) preferred the study eye’s dropless regimen over the control eye’s conventional topical therapy regimen. No statistically significant difference in mean intraocular pressure (IOP) was observed at any postoperative visit, except at Week 1. The mean CDVA was also similar in both groups at all postoperative visits (p>0.05). The postoperative mean CRT was comparable between the two groups.

Conclusion

A dropless treatment regimen is as effective as topical eyedrop administration. A higher proportion of patients who underwent bilateral cataract surgery preferred the dropless treatment regimen over the patient-administered eye drop regimen.

Keywords:

• dropless cataract surgery
• intracanalicular dexamethasone insert
• dropless vs topical eyedrop administration
• sustained-release steroid delivery
• drop-free treatment regimen

Abbreviations

SOIS, Summed ocular inflammation score; QID, 4 times a day; BID, 2 times a day; CDVA, Corrected distance visual acuity; OCT, Optical coherence tomography; AE, Adverse events; COMTOL, Comparison of ophthalmic medications for tolerability; CRT, Central retinal thickness; LOCS, Lens opacity classification system; IOP, Intraocular pressure; NSAID, Non-steroidal anti-inflammatory drugs; RLE, refractive lens exchange; FDA, Food and Drug Administration.

Data Sharing Statement

The data that support the findings of this study are available from the corresponding author, (EDD), upon reasonable request.

Acknowledgments

Raman Bedi, MD (IrisARC - Analytics, Research & Consulting) and Jan Beiting (Wordsmith Consulting) provided statistical and editorial assistance in the preparation of the manuscript. Partial results of this paper were presented at the 2020 ASCRS Virtual Annual Meeting.

Disclosure

Drs. Donnenfeld and Hovanesian are consultants to Ocular Therapeutix and Rayner. Dr Donnenfeld also reports grants from Omeros. Dr Hovanesian also reports grants, personal fees from EyePoint, outside the submitted work. The authors report no other conflicts of interest in this work.

Additional information

Funding

Funding to conduct this study and for editorial assistance was provided by Ocular Therapeutix. The authors retained full control of manuscript content.