Through a recent acquisition, Bausch + Lomb has added the IC-8 IOL to its portfolio, featuring small aperture intraocular technology that Australian ophthalmologists say is addressing unmet needs in various scenarios.
It’s one of the great paradoxes of modern-day ophthalmology. The fact cataract surgeons have access to an expanding suite of advanced intraocular lens (IOL) designs, one would expect their job has never been easier. Yet, there has never been greater demands on their technique and technical knowledge, partially driven by more patients seeking spectacle independence – regardless of their ocular physiology.
More sophisticated multifocal and extended depth of focus (EDOF) IOLs have made it possible to satisfy an increasing desire for presbyopia correction. But the ophthalmologist still needs to consider multiple variables and manage the patient’s expectations before the final IOL is selected.
For instance, cases of corneal irregularity may render some patients ineligible for certain traditional premium lenses featuring complex optics that split, shift or stretch light to achieve clear vision at more than one focal point. Or on the other hand, myopic cataract patients may baulk at the thought of losing excellent unaided near vision they’ve enjoyed for most of their adult life, if offered with a monofocal IOL.
The IC-8 IOL – adopting small aperture intraocular technology – is one lens working to address several unmet needs in eyecare, as several Australian ophthalmologists are attesting to. The IOL was originally developed and commercialised by AcuFocus but was acquired by Bausch + Lomb earlier in 2023.
The IC-8 IOL was first launched in the Australian market in 2015 for cataract patients seeking near, intermediate and distance vision with increased spectacle independence. And in July 2022, it became the first and only small aperture non-toric EDOF IOL of its kind approved in the US.
It is recommended for unilateral implantation in the non-dominant eye with an aspheric monofocal or toric monofocal IOL in the dominant eye. All in all, it can provide over 2.00D of extended depth of focus, tolerate up to 1.00 D deviation from the target manifest refraction spherical equivalent, and accommodate as much as 1.50 D of corneal astigmatism.
Sydney ophthalmologist Associate Professor Chameen Samarawickrama – an expert in complex corneal disease – says the IC-8’s unique design has also garnered impressive results in several of his patients with irregular corneas such as keratoconus, pellucid marginal degeneration, corneal dystrophies, and those with a history of corneal trauma or herpetic eye disease”.
“This is because of its ability to address irregular astigmatism, making it the most optimal lens on the market currently that can do so”, he says.
“We know these patients can’t obtain good vision from glasses and the same happens with a standard IOL – they end up 6/7.5, 6/9 or worse and sometimes contact lenses are the only way to improve their vision [post-operatively].
“What the IC-8 does better than any other lens, is neutralises the irregular astigmatism component of their cornea through its pinhole technology. I’ve had patients who historically have never been better than 6/9 in glasses achieve 6/6 or 6/7.5, once implanted with the IC-8. Many remark they’ve never seen this well in their life. Those with more mild corneal disease can achieve remarkably good distance, intermediate and near vision too. The classic example is a mild keratoconus patient where it’s not uncommon to achieve 6/6 for distance, and N6, N7 or N8 for near unaided vision.”
Crucial to this, says Samarawickrama, is the embedded FilterRing Component in the IC-8 design, which blocks scattered, defocused and aberrated peripheral light, but allows the passage of paraxial, central light rays.
“But it also has an elongated interval of Sturm and, because of this, the lens is able to achieve greater depth of focus and range of vision as a result,” he says.
Samarawickrama says it’s also important to point out the IC-8 addresses regular astigmatism in his patients too. And in cases of residual regular astigmatism, he has implanted a piggyback cylindrical IOL in the sulcus to achieved 6/6 unaided vision when they have historically never been able to do so before.
He has audited his IC-8 cases in patients with irregular astigmatism, which he presented at the RANZCO Congress in Perth in October 2023. This was rounded off with a case report on a severe keratoconus patient with -6.00 D of astigmatism. The patient was contact lens dependent and only saw 6/18 in glasses, but was developing cataracts that dropped her vision further.
Ultimately, he implanted the IC-8 that – while being able to tolerate up to -1.50D of corneal astigmatism – managed to neutralise a surprising -4.00 D of cylinder in this patient.
“This was followed with a piggyback cylindrical lens in the sulcus leaving her 6/5 for distance and surprisingly N5 for near, all unaided,” he says.
For fellow ophthalmologists considering the IC-8 in their patients, Samarawickrama says it’s important to note the IOL only comes in spherical powers. With a pinhole design allowing less light to the retina, some patients may also report slight reduction in the visual field, and a longer time adapting from light to dark environments.
“But in patients with abnormal corneas, the improved visual acuity is so dramatic, that they don’t even notice any of the other symptoms,” he says.
Other surgeons have noted IC-8’s reputation as a forgiving lens, tolerating up to 1.00 D deviation from the target manifest refraction spherical equivalent.
“I would agree it’s a forgiving lens,” he says. “Instead of a pinpoint target, the calculations gives you a higher and a lower anticipated zone, providing a soft landing, which is very comforting as a surgeon,” Samarawickrama says. “For those starting out, the keratoconus patient is ideal because invariably there is more irregular astigmatism and spherical aberration present, and these patients will achieve improved quality of vision, which they will thank you for.”
Overcoming the intolerances of myopic cataract patients
Since the advent of presbyopia-correcting IOLs, Melbourne corneal and cataract surgeon Dr Alex Poon has made it a priority to discuss these with every patient.
“But I think it’s about targeting certain lenses for certain individuals,” he says.
When he first became aware of the IC-8 around five years ago, he saw its suitability in patients with irregular corneas. But he was also excited about its potential in myopic cataract patients. In his experience, this patient group didn’t always respond well to multifocal IOLs because of reduced contrast compared to their original vision.
In his experience, these patients also have high expectations, largely due to the fact many have good unaided near vision prior to needing cataract surgery.
“For example, a -3.00 D myope has a focal point of around 30cm, meaning they can read quite well. So if they have inferior near vision post cataract surgery with a monofocal IOL, they will often complain about why their vision is worse, if they weren’t warned about it.”
To understand this in greater detail, Poon conducted a retrospective study of 25 myopic cataract patients implanted with the IC-8, from his private clinic. This was published in the Hong Kong Journal of Ophthalmology. All had myopia (≥-0.25 D) in both eyes and astigmatism (≤-2.50 D) in the non-dominant eye and were assessed after six months. Patients had a monofocal IOL targeting plano in the dominant eye and the IC-8 in the nondominant eye targeting -1.00D to -1.25D.
Binocularly, 92% of patients achieved uncorrected distance of logMAR 0 or better, 64% recorded uncorrected intermediate vision of logMAR 0 or better, and 100% logMAR 0.20 (N5) or better for near vision.
Ultimately, he was able to show the IC-8 can extend the depth of focus and is a good option for patients with myopia who can tolerate monovision. It also provides good binocular uncorrected distance, intermediate, and near visual acuity when used in conjunction with a monofocal IOL in the dominant eye.
Poon did note that some patients may experience dysphotopsia symptoms, but the symptoms are not frequent, severe, or bothering.
For patients who might not be as tolerant of traditional monovison, he believes the IC-8 is advantageous because it provides depth of focus in the non-dominant eye, potentially decreasing the sensation of blur and improving stereopsis for distance, besides providing for unaided near vision.
“It’s quite easy to convince patients to consider this IOL, because in the clinic we can all demonstrate to patients how their short sightedness can be corrected with a pinhole. When you explain we can incorporate this principle into the IOL, the IC-8, it’s simple for them to understand,” he says.
“But with all lenses it’s important to warn patients about any potential disadvantages. Some things I mention is the potential for poorer vision in dim light (24% of patients in the study were dissatisfied with vision in dim light compared to 4% in bright light), and when driving at night they may experience some starbursts and halos. And, in my study, the laser capsulotomy rate was higher with this lens than a monofocal IOL (72% vs 48%).”
For B+L, the IC-8 is playing an important role in its premium IOL portfolio, which today also includes the LuxSmart, an IOL offering an extended range of vision launched earlier in 2022. The global premium cataract IOL market is projected to grow at a compounded annual growth rate of 13% between 2022 and 20272.
Both Poon and Samarawickrama are pleased to see a company of Bausch + Lomb’s size and reputation bring IC-8 into its sphere, potentially broadening its availability.
“With the addition of the IC-8 lens, Bausch + Lomb continues to expand its premium IOL portfolio offering,” says Ms Marion Bastier, head of global IOL strategy and international director of marketing at Bausch + Lomb Surgical.
“Through the IC-8 IOL, we continue our commitment to provide surgeons with solutions to address their patients’ daily visual needs.”
1. Food and Drug Administration. (2002). IC-8 Apthera Intraocular Lens (IOL) – P210005: FDA Summary of Safety and Effectiveness Data. Accessed April 27, 2023. https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210005B.pdf.
2. Market Scope. 2022 IOL Market Report (April 2022).