Any experience/info about the AcuFocus IC-8 IOL?

This is the specification.

note; the pin hole aperture  is only 1.36mm.

IOL Material

– Hydrophobic acrylic

• IOL Design

– Single-piece

– Biconvex, anterior aspheric surface optic

– 6.0 mm optic diameter

– 12.5 mm overall length

– Modified C haptic with 5° angulation

• Mask Design

– Polyvinylidene fluoride (PVDF) and nano-particles of carbon

– 1.36 mm aperture

– 3.23 mm total diameter

• A-Constant for Optical Biometry:120.5

• A-Constant for Ultrasound Biometry: 120.15

• Surgeon Factor: 2.64

• Diopter Range: +15.5 D to +27.5 D (0.50 D steps)

Hi John

I have had a symfony exchanged for an IC-8 and my description has been posted

Pinhole looks a good thing wearing pinhole glasses: the corneal aberrations are cut off and you can read well, but it's something OUT your eye. Once the lens is INSIDE your eye, you'll sight will be darkened, sometimes to the point you wont be able to drive at night. Not a good thing.

I'm getting tbe IC-8 IOL on Wednesday. Anyone on here have this lens?

I will update on my experience.

I’m in Australia, where I believe this lens has been approved for a couple of years.

Over the past several months I have been reading everything I could find on the IC-8.

In this thread so far, there is a lot of misinformation and uninformed speculation, presented as fact, that is contradicted by the actual scientific evidence. I think if anyone described a 747 to an audience that had never seen an airplane fly, many would confidently post that a 900,000-lb metal machine could not fly. As always, it's wise to look at evidence before passing judgement.

The IC-8 has been very well received. Some trials ended up reporting on bilateral implantation. They started out intending to do only one eye in each patient, but some of the trial subjects liked the first one they got so much they insisted on having it in the other eye as well. And they liked it. Subjects receiving bilateral implantation achieved higher visual accuity -- half achieved 20/16, while no unilateral subjects achieved better than 20/20.

It's hard to imagine how the IC-8 would have the high patient satisfaction scores it has if it gave great difficulty in night driving. See the article "The IC-8 IOL: Big Advantages Through Small Apertures ." Quote from that article:

"Auffarth and Srinivasan state that none of their patients has reported significant night vision difficulties; similarly, Beltz reports that her patients have very high satisfaction with vision in dim light: 'The mean satisfaction scores for dim light and bright light vision were equivalent.'"

It's aperture is only 1.3 mm, yet you can see at night. It is 900,000 lbs, yet it can fly.

The lens has been sold for years in Europe, Australia and some other countries. It was approved by the FDA here in July. At the recent ophthalmologists convention, the manufacturer's reps told my ophthalmologist distribution here (USA) would begin in the first quarter of 2023.

If you want a summary of all the published clinical results to date, search for "Small Aperture IC-8 Extended Depth of Focus Intraocular Lens in Cataract Surgery: A Systematic Review."

Here is a quote from the abstract:

"Significant

improvements in uncorrected distance visual acuity (UDVA); uncorrected intermediate visual acuity

(UIVA); uncorrected near visual acuity (UNVA); perception of photic phenomena; and patient

satisfaction have been reported. Unilateral and bilateral small aperture IC-8 IOL implantation reduces

photic phenomena and provides good vision for all distances with high patient satisfaction and

minimal postoperative complications."

From the results section:

"Regarding patient satisfaction, Grabner et al. [24], Dick et al. [25,26], Hooshmand et al. [27],

Ang [41], Ang et al. [28], and Schojai et al. [29] assessed this variable with the satisfaction

questionnaire score, where a score of 1 indicated very dissatisfied and 10 very satisfied.

All these studies reported a high satisfaction questionnaire score after small aperture IC-8

IOL implantation." (Most were in the 8 to 9 range).

On the question of seeing in dim light -- Ang (Visual Performance of a Small-Aperture Intraocular Lens: First Comparison of Results After Contralateral and Bilateral Implantation) gives the most thorough report:

"Under mesopic conditions (bottom left and bottom right), the mean log contrast sensitivity was on average approximately 0.2 log units lower in the IC-8 IOL eyes compared to monofocal eyes, although none of the differences was statistically significant at any spatial frequency with or without glare conditions (P > .05)."

I confirmed with my ophthalmologist that 0.2 log units is pretty close to bupkis . Note that they could not reject the null hypothesis at the 5% level. And this is testing one eye at a time. When binocular vision was tested in other studies, with unilateral implantation of the IC-8 and a conventional monofocal in the fellow eye, there was no difference in contrast sensitivity vs. patients with conventional monofocals in both eyes.

Night driving satisfaction scores were slightly HIGHER for those who got bilateral implantation of the IC-8, Ang said. However, it was a biased sample in that only those who requested the IC-8 for the second eye got it. So, this group probably had the best results on the first eye. The unilateral subjects did not request IC-8 for the second procedure and got a standard monofocal in the other eye.

All 20 of Ang's subjects said they would choose the IC-8 again if they had it to do over.

According to an article (Ring Me Up) in the April 15 2022 Review of Optometry "It is a one-piece hydrophobic, acrylic IOL with a 6mm optic zone, 12.5mm length and powers that range from +10D to +30D in 0.50D steps."

Please note this contradicts information posted in this thread by others, in regard to over-all size (it is 12.5mm) and range of powers (it is 10D to 30D). Someone already corrected the over-all size info. This corrects the range of powers.

The IC-8 is the only non-toric lens that can correct astigmatism. It's good up to 1.5 d of cyl. That's a great thing, since it does not depend on the doctor getting the axis right and the lens not rotating.

The IC-8 solves some really gnarly vision problems caused by higher-order aberrations in the cornea.

I am wavering about whether to get the IC-8. I don't care that much about being glasses free but I care a lot about having the best possible vision for the task at hand. That probably means conventional monofocals and two different pairs of glasses. But, that thinking could change.

Bausch & Lomb has bought AcuFocus, the inventor/manufacturer of the IC-8.

Bausch + Lomb Acquires AcuFocus, Inc.

Acquisition Will Enhance Bausch + Lomb’s Surgical Portfolio with IC-8® Apthera™ Intraocular Lens

January 17, 2023 05:09 PM Eastern Standard Time

VAUGHAN, Ontario & IRVINE, Calif.--(BUSINESS WIRE)--Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and AcuFocus, Inc. (“AcuFocus”), a privately held ophthalmic medical device company, today announced that an affiliate of Bausch + Lomb has acquired AcuFocus, pursuant to a merger transaction with the parent company of AcuFocus.

AcuFocus has delivered breakthrough small aperture intraocular technology to address the diverse unmet needs in eye care, including the IC-8® Apthera™ intraocular lens (IOL), which was approved by the U.S. Food and Drug Administration in July 2022 as the first and only small aperture non-toric extended depth of focus (EDOF) IOL for certain cataract patients who have as much as 1.5 diopters of corneal astigmatism and wish to address presbyopia at the same time. Known as the IC-8 IOL in global markets, this IOL is available in select markets across Europe, as well as in Australia, New Zealand and Singapore.

New article on the IC-8 small aperture IOL, recently purchased by Bausch & Lomb and rolling out in the US ever so slowly.

Google

Early Experiences with the IC-8 Apthera IOL

By John A. Hovanesian, MDJune 1, 2023

Excerpts:

"Our results show that the IC-8 Apthera is very effective for improving near vision in 1 eye. More specifically, the lens can be used with patients who have been accustomed to monovision in the past, are considering monovision, or who have irregular astigmatism."

"In our practice, our initial goal was to use the IC-8 Apthera, in some cases off-label, for patients in whom we normally wouldn’t use an advanced optic lens because they had significant optical aberrations in their corneas, perhaps from previous corneal surgeries, such as RK or LASIK. Typically we would steer such a patient away from the most common advanced lens we would use, which is a diffractive multifocal lens. In those patients, we saw success with the IC-8 Apthera’s ability to extend the depth of field over a fairly wide range."

"We’ve also used the lens with patients who have had no previous corneal surgeries. We’ve enjoyed pairing the IC-8 Apthera with enhanced monofocal lenses that provide a little extra depth of focus. Keeping patients slightly on the myopic side to move the defocus curve slightly into the nearsighted side is where the Apthera shines.

The FDA clinical trial data show that there’s just shy of about 2D of extended depth of focus with Apthera. That puts patients at good intermediate vision and decent near vision. That’s where that target becomes so important because, if you can move patients slightly on the myopic side, then you extend that 2D range, which improves near vision.

Compared with other advanced implants, I’ve been impressed with the IC-8 Apthera’s image quality. With the FilterRing, you eliminate some of the peripheral light rays that could impair image quality."