Pearls to enhance patient comfort and streamline cataract surgery

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Patient comfort is a crucial aspect of cataract surgery. At my practice, we take steps to ensure patients are relaxed before and during the procedure because it helps minimize their anxiety as well as their stress levels. One essential element of patient comfort in the operating room is pain management. An effective pain management strategy not only enhances the patient experience but also streamlines surgery day for the surgeon and their staff. To build an effective strategy, consider using both verbal and ocular anesthesia techniques.

Verbal anesthesia

Verbal anesthesia involves the use of gentle and positive verbal cues, imagery, and suggestions that help guide patients through the procedure. When used effectively, verbal anesthesia induces a state of heightened suggestibility and relaxation for patients, facilitating a more receptive attitude toward the safety of the procedure and reducing their response to pain stimuli. Not only can verbal anesthesia relax patients, but it helps them cope with the sensory experiences associated with surgery such as bright lights, sounds, and sensations of pressure.

Verbal anesthesia has been shown to be an effective component of managing pain and anxiety,¹ and therefore is an important adjunct to ocular anesthesia. The latter is the most essential provision of a comprehensive pain management program.

Innovation in ocular anesthesia

The best way to treat pain is to avoid it with proper use of medications. Although a wide range of ocular anesthesia techniques is available—including peribulbar injection, retrobulbar injection, and topical therapies—there has not been much innovation in this area in more than a decade. Most surgeons routinely use a combination of techniques to achieve adequate ocular anesthesia. As we continue to progress toward streamlined surgery, however, simpler is better. I favor an ocular surface approach to anesthesia that allows me to use as few products as possible.

Chloroprocaine hydrochloride ophthalmic gel 3% (Iheezo; Harrow Eye, LLC) is the first topical anesthetic studied in a surgical model for FDA approval. The product provides complete ocular surface anesthesia within about 1 minute of a single dose of 3 drops and has a duration of about 22 minutes. The sterile, preservative-free ophthalmic gel can be used on nearly any patient except for those with a history of hypersensitivity to any component of the preparation. I use it in any patient who is indicated for topical anesthesia, mostly for cataract surgery.

Study results

In a phase 3 clinical trial of chloroprocaine hydrochloride ophthalmic gel 3% in patients undergoing routine cataract surgery, there was no reported need for supplemental anesthesia or analgesia treatment to complete the intended surgical procedure for patients randomly assigned to the gel. In addition, no administration of opioids was required. Some patients who were randomly assigned to tetracaine reported moderate or severe intraoperative pain whereas none in the chloroprocaine hydrochloride ophthalmic gel 3% group did.²

Patients in the trial were randomly assigned to receive chloroprocaine hydrochloride ophthalmic gel 3% (n = 167) or tetracaine 0.5% solution (n = 171) for anesthesia and pain management. They were asked to rate their pain levels before the first incision, after capsulorhexis, at the end of phacoemulsification, and before IOL insertion.

Just before IOL insertion, a similar number of patients in the chloroprocaine group had successful anesthesia compared to the tetracaine group (92.1% vs 90.5%, respectively). The former also had a shorter time to achieve ocular anesthesia (≤ 1.5 min) and a mean duration of effectiveness of 22.5 minutes. Tolerability and safety were superior in the chloroprocaine group.

Data from this study showed that chloroprocaine hydrochloride ophthalmic gel 3% can be used as a standalone strategy to achieve complete ocular anesthesia and manage intraoperative discomfort and pain for the duration of a routine cataract surgery procedure without the need for opioid sedation.

Clinical observations

I have now performed hundreds of cataract procedures with chloroprocaine hydrochloride ophthalmic gel 3%. Importantly, I have been able to eliminate the need for intraocular lidocaine, which in the past I considered essential for achieving a greater depth of anesthesia, particularly for patients who required higher infusion pressure or were myopic. Both these groups tend to have more pain during surgery.³ Incorporating chloroprocaine hydrochloride ophthalmic gel 3% into my cataract surgery routine has been a positive development, both in terms of patient experience and cost savings.

Another positive development is the synergy of chloroprocaine hydrochloride ophthalmic gel 3% with a drop-free cataract surgery regimen. I consider the entire spectrum of ocular interventions as a cohesive strategy and, whenever possible, combine chloroprocaine hydrochloride ophthalmic gel 3%, phenylephrine and ketorolac intraocular solution 1%/0.3% (Omidria; Rayner), intracameral moxifloxacin, and slow-release steroids such as dexamethasone ophthalmic insert 0.4 mg (Dextenza; Ocular Therapeutix, Inc) to provide a more comfortable surgical experience for patients. Eliminating topical administration of anesthesia, antibiotics, and nonsteroidal anti-inflammatory drugs puts patient comfort at the forefront.

It is also important to note that using chloroprocaine hydrochloride ophthalmic gel 3% can help facilitate a reduction in opioid prescriptions after cataract surgery. My anesthesiologist reported that we use considerably less opioids, particularly in our ambulatory surgery center (ASC), since adopting this comprehensive strategy. We still occasionally prescribe opioids to control anxiety during surgery and provide additional sedation, but the social effects of opioid use and opioid use disorder are major deterrents.⁴

The use of chloroprocaine hydrochloride ophthalmic gel 3% therefore aligns with the contemporary emphasis on reducing opioid use in medical procedures. Research in this area is ongoing. Donnenfeld et al showed a reduced need for opioids when phenylephrine and ketorolac intraocular solution 1%/0.3% was added to a surgical protocol.3 In the future, we plan to conduct a study on the comparative use of opioids with and without chloroprocaine. I suspect our results will show clearly that there is less need for opioids with it.³

Overcoming the learning curve

Moreover, the FDA approved chloroprocaine hydrochloride ophthalmic gel 3% in 2022. It has been gaining popularity, but not all surgeons are early adopters of technology. I think it is important to consider, however, that the use of a uniquely effective topical anesthetic such as chloroprocaine hydrochloride ophthalmic gel 3% can both enhance patient comfort and streamline efficiency. In my clinic, the transition to this regimen was relatively straightforward. The protocol was simple and easily adopted by our nursing staff.

Overcoming financial concerns can be a minor hurdle, as separate insurance coverage and reimbursement are involved, but it is manageable with proper training and support. Most notable, billing staff must verify insurance coverage, which is universal for Medicare Part B.

The Centers for Medicare & Medicaid Services approved transitional pass-through reimbursement status for chloroprocaine hydrochloride ophthalmic gel 3% in April 2023. It is eligible for separate reimbursement outside of the surgical bundled payment in both ASCs and hospital outpatient departments (HOPDs) for the next 3 years, and chloroprocaine hydrochloride ophthalmic gel 3% has a permanent, product-specific J-Code (J2403) for the inoffice setting of care. Pass-through status typically allows surgeons to be reimbursed by Medicare at an average sales price (ASP) plus 6% in ASCs and HOPDs. Until an ASP is established for chloroprocaine hydrochloride ophthalmic gel 3%, it will be reimbursed accordingly at wholesale acquisition cost plus 3%.

There has been significant cost savings to our practice, alleviating the burden of bundled costs for medications such as lidocaine, tetracaine, and other topical drops in the ASC. Instead, we are using an item that costs us nothing and costs the patient nothing. It is a win for our practice and a win for our patients.

Conclusion

The role of effective and efficient anesthesia for patient comfort during cataract surgery cannot be overstated. Chloroprocaine hydrochloride ophthalmic gel 3% is the first true development in ocular anesthesia in 14 years, revolutionizing patient care and offering both clinical benefits and economic advantages.

The integration of chloroprocaine hydrochloride ophthalmic gel 3% into a broader drop-free cataract surgery strategy sets the stage for a patient-centric and streamlined approach to cataract surgery. Surgeons navigating this paradigm shift stand to benefit from enhanced patient comfort and overall satisfaction, reduced reliance on opioids, and the financial advantages of optimized anesthesia protocols.

John A. Hovanesian, MD

E: drhovanesian@harvardeye.com

Hovanesian is in private practice at Harvard Eye Associates in Laguna Hills, California. He is a consultant to or investor in Alcon, Bausch + Lomb, Carl Zeiss Meditec, and Johnson & Johnson Vision.

References:

1. Mokashi A, Leatherbarrow B, Kincey J, Slater R, Hillier V, Mayer S. Patient communication during cataract surgery. Eye (Lond). 2004;18(2):147-151. doi:10.1038/sj.eye.6700568

2. Lindstrom RL. Prospective, randomized comparison of chloroprocaine 3% gel and tetracaine 0.5% solution for cataract surgery anesthesia. Paper presented at: American Society of Cataract and Refractive Surgery Annual Meeting; May 5-8, 2023; San Diego, CA.

3. High myopia and cataract surgery. American Academy of Ophthalmology. Practicing Ophthalmologists Learning System. Accessed September 28, 2014. http://one.aao.org/pols-snippet/2217

4. Donnenfeld ED, Mychajyszyn D, Mychajlyszyn A, Stein R. Pain control and reduction of opioid use associated with intracameral phenylephrine 1.0%–ketorolac 0.3% administered during cataract surgery. J Cataract Refract Surg. 2022;48(7):759-764. doi:10.1097/j.jcrs.0000000000000855