BVI’s IPure lens optimizes placement, gets results

There is a common mantra in ophthalmology: Under-promise and over-deliver.

In my practice, I will only consider using products that I know are going to perform well and not increase my daily stresses. While patients can attribute their positive outcomes to the surgeons, we all know that part of any successful outcome is highly dependent on the products that we routinely use.

BVI launched IPure, its first intraocular lens, in the United States one year ago. It is the first and only fully pre-loaded aspheric monofocal intraocular lens (IOL) available in the United States in both a one-piece and three-piece design to treat patients undergoing cataract surgery. Shortly after its introduction, my own investigation, and an ample vetting period, I began using it routinely and have attained great success.

HOW IT WORKS

BVI’s IPure IOL is delivered through a disposable, pre-loaded injector to optimize its implantation.It provides streamlined operating procedures through eliminating time-consuming steps; merely requiring the injector to be prepared with the ophthalmic viscosurgical device (OVD), and then the IOL is inserted.

Its aspheric optic design provides high contrast in various lighting conditions, while maintaining natural corneal depth of focus for those patients undergoing cataract surgery. Additionally, it is less sensitive to off-axis conditions, lens decentration, and corneal aberration.

The IPure IOL delivery time is an average of 22 seconds versus up to 43 seconds with manually loaded delivery systems.

The three-zone aspheric optic design provides neutral spherical aberration in the ~2.4 mm central optic zone (zones 1 and 2) and-0.18 microns spherical aberration in the peripheral optic zone.

The IPure’s individually lathe-cut and pad-polished lenses provide a smooth and even optic surface designed to reduce light scattering on lens surface¹ and a sharp optic edge designed to reduce posterior capsule opacification. Blue PMMA chemically bonded haptic tips are highly visible inside the injector for controlled folding behavior, with reduced sticking of materials.²

Both B1PC (one-piece, clear) B1PY (one-piece, yellow) and B3PC (three-piece, clear) utilize hydrophobic acrylic and UV filter optical material. The haptic configuration is a modified C loop with a 5-degree angulation. The optic/IOL dimension measures 6.0 mm/12.5 mm.

The A-Constant is 118.4, although it is recommended that the measurement be customized based on a surgeon’s experience and measurement equipment.

CLINICAL STUDIES

In a study of 600 IOL release bench tests, 100% normal lens releasing behavior was seen with IPure.³

In a human trial comparing pre-loaded and non-pre-loaded IOL delivery systems, 0% of IPure cases required additional IOL manipulations in the eye versus up to 32% of the cases utilizing manually loaded IOL delivery systems.²

No leading haptic/trailing haptic failure was seen in 201 IOL release bench tests.⁴

EASE OF USE

For me, the driving factor for using this IOL is that it is a pre-loaded delivery system. Oftentimes, I will make a 2.4 mm corneal incision for the main wound. When I am injecting the lens, it has traditionally always been a tight fit, requiring a bit of a struggle to get the injector system into the eye.

With the IPure IOL system, the lens slides in very easily and effortlessly. I feel like I am putting less strain and stress on the corneal wound, in addition to being able to improve my surgical time given the enhanced workflow efficiencies and productivity designed into the product from start to finish.

The IPure IOL is also meeting what has been to date an unmet need in the market: a three-piece pre-loaded intraocular lens. Oftentimes, surgeons like using three pieces of their primary lens. I usually use them as my backup lenses.

For example, if I have a patient with a capsular bag rent without vitreous, I would feel safe using a three-piece lens in the sulcus or optic captured. Previously, to employ a three-piece IOL, I would need to load the lens myself (given the infrequency of use coupled with the technicians unfamiliarity), enlarge the wound for the increased cartridge size, and finally place a 10-0 nylon suture to ensure the main wound is sealed at the end of the case.

However, with the advent of the IPure IOL three-piece preloaded system, I have yet to add a single step to my cases in one-off events such as these. I'm now able to just inject the lens into the eye and feel good about the size of the incision. I don't need to enlarge the wound, and as long as I'm pretty confident that there's no vitreous, I am can perform routine self-sealing wound hydration without any sutures.

CANDIDATES AND OUTCOMES

Everyone is a good candidate for the BVI IPure B1PC and B3PC.

Anecdotally, I have been finding that these patients are getting some decent intermediate vision when plano is targeted. I have been receiving more unsolicited responses telling me that they're able to use their computer easily without any reading glasses, despite my preoperative counseling informing them that they will absolutely need glasses for intermediate and near. In this regard, the IPure IOL has been very beneficial to my patients in that they're getting enhanced vision without an enhanced price tag.

IMPACT ON THE PRACTICE

The use of the lens has had a positive impact on my practice. Like many others, I rely on the benefits from positive word-of-mouth and people doing well after modern-day cataract surgery.

As a relatively young ophthalmologist, I'm trying to grow my practice and always looking for the best technologies available to my patients to ensure they have positive outcomes.

Without a downside, integrating the IPure IOL system into my routine practice has undoubtedly helped me become more successful, grow the practice, and provide my patients with positive outcomes. ■

References:

1. Werner L. Glistenings and surface light scattering in intraocular lenses. J Cataract Refract Surg. 2010;36(8):1398-1420.
2. Chung B, Lee H, Choi M, et al. Preloaded and non-preloaded intraocular lens delivery system and characteristics: human and porcine eyes trial. Int J Ophthalmol. 2018;11(1):6-11.
3. Data on file, HOYA Medical Singapore Pte. Ltd, 2012.
4. Data on file, HOYA Medical Singapore Pte. Ltd, 2012.