Evaluation of the Real World Outcomes of the Tecnis Eyhance Intraocular Lens Implant in Cataract Surgery

Ruth Ellard¹, Emily Hughes², Edward Loane³

¹Royal College of Surgeons Ireland

²University Hospital Galway, Galway

³Royal Victoria Eye & Ear Hospital, Dublin

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Abstract

Purpose: To evaluate real world visual outcomes of patients in terms of distance and intermediate vision using the Tecnis Eyhance™ intraocular lens (IOL), an enhanced monofocal IOL.

Methods: An observational study of 50 consecutive patients who underwent cataract surgery using the J&J Tecnis Eyhance™ IOL implant were reviewed 1 month postoperatively. At this post- operative review a clinical examination was performed assessing intraocular pressure and presence/ absence of uveitis. Visual acuity in LogMAR was measured at distance unaided, with distance correction and with pinhole. Intermediate vision at 70cm was measured on LogMAR to a maximum of 0.3 and with a near visual acuity chart.

Results: There were no intraoperative or early post-operative complications. The average best corrected distance visual acuity was 0.084 LogMAR. 69% of eyes had corrected distance VA >/= 0.1 LogMAR (6/7.5), 89% >/=0.2LogMAR (6/9.5) and 100% > 0.4 LogMAR (6/15).

At 70 cm 78% of eyes had DCIVA of at least 0.3LogMAR and 95% of eyes had DCIVA of 0.4LogMAR or better.

Conclusion: The Tecnis Eyhance IOL was found to be as easy to use as the current alternative IOLs surgically. It provided excellent distance visual acuity and in addition to this approximately half had intermediate vision of N12 or better and all all patients had intermediate vision of N36 or better

This results of this IOL demonstrated that the Tecnis Eyhance™ IOL is a safe alternative to monofocal IOLs and has the potential to give patients reasonable spectacle independence for intermediate tasks.

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Background/Introduction:

Cataract surgery is one of the most common surgeries performed worldwide¹. The standard is to replace the natural lens with a monofocal intraocular lens (IOL) implant that usually targets good distance vision. Patients lose all ability to accommodate for intermediate and near work when their own crystalline lens has been removed and so, require spectacles to be able to focus at intermediate and near distances. The visual demands in the modern world require a lot more use of intermediary distance, thus making post-operative cataract patients more dependent on spectacles. Cataract surgery is turning into a refractive surgery¹ with patients having higher expectations of the post- operative visual results. One alternative treatment option is a multifocal IOL. Although they provide functional vision at multiple focal lengths they are well known to have unwanted side effects².

These include increased higher order aberrations, reduced contrast sensitivity, photic phenomena and an increased cost compared to standard IOLs. Another alternative treatment option is monovision with monofocal IOLs, targeting one eye for distance vision with emmetropia and the other for near vision (myopia). Ocular dominance is ascertained and emmetropia is targeted in the dominant eye and myopia in the non-dominant. The side-effects of monovision include reduction in stereopsis, reduction in contrast sensitivity and asthenopia³. There can also be difficulty in identifying the dominant eye, which can be different depending on how it is assessed⁴. Motor, sighting and sensory dominance are not always aligned^5,6. Ocular dominance can change with the development of cataract, and after cataract surgery⁷, making the identification of ocular dominance and decision which eye to target emmetropia difficult. Mini-monovision is a variant of monovision with a refined adaptation of traditional monovision employing milder anisometropia (-0.75 to -1.50 diopter)⁸ but still has an impact on stereopsis. Its success is influenced by factors such as ocular dominance, pupil size, neuroadaptive capacity, and precision of refractive targeting⁸.

Enhanced IOLs are a newer alternative to multifocal and monovision, offering an extended depth of focus without the side-effects or significant cost of multifocal IOLs.

The Johnson & Johnson Tecnis Eyhance™ IOL (ICB00) implant was one of the first in the new generation of enhanced monofocal IOLs. It has a refractive surface design that's progressive in power from the periphery to the centre of the lens. This allows it to still provide excellent distance vision offered by monofocal IOLs as well as providing the additional benefit of some intermediate vision without the need for spectacles.

Materials and Methods:

50 consecutive patients who underwent cataract surgery on one service had the Johnson & Johnson Tecnis Eyhance™ IOL implanted and were reviewed 1 month postoperatively. This IOL is a one piece acrylic aspheric refractive foldable posterior chamber IOL. It is designed for placement in the capsular bag. The surgeries were performed by 3 surgeons on the one service. Biometry was measured using the Zeiss IOLMaster 700 and the target refraction was for emmetropia. Standard phacoemulsification through a manual clear corneal incision was performed and a continuous curvilinear anterior capsulorhexis was performed manually. The IOL itself is preloaded in an injector and is similar to other injectable IOLs, so there was no technical learning curve involved in insertion for the surgeons. In all cases the IOL was inserted into the capsular bag. The wounds were confirmed to be self-sealing and no sutures were required.

At the one-month post-operative review, a comprehensive clinical examination using slit lamp biomicroscopy was performed to assess intraocular pressure, presence/absence of uveitis, and unilateral visual acuity in LogMAR was measured at distance unaided, with distance correction and with pinhole. Intermediate vision at 70cm was measured on LogMAR to a maximum of 0.3 and with a near visual acuity chart.

Results and Discussion:

Of the 50 patients, the results of 45 were reviewed. Exclusion criteria included macular pathology which may be a confounding factor on the visual acuity measurements and incomplete records. 4 were excluded due to the former (macular degeneration and epiretinal membrane) and one for the later.

27 right eyes were operated on and 18 left eyes. The break down of male to female patients was 22 to 23 females. There were no intraoperative or early post-operative complications noted. No eyes had post-operative uveitis or macular oedema.

The mean age of the patients was 71.22 years with a range from 30-90 years. The average uncorrected post-operative distance visual acuity was 0.182 LogMAR and the average best corrected distance visual acuity was 0.084 LogMAR. 69% of eyes had corrected distance VA >/= 0.1 LogMAR (6/7.5), 89% >/=0.2LogMAR (6/9.5) and 100% > 0.4 LogMAR (6/15).

At an intermediate distance of 70cm 78% of eyes had DCIVA of at least 0.3LogMAR and 95% of eyes had DCIVA of 0.4LogMAR or better.

At 70cm 20% had distance corrected intermediate visual acuity (DCIVA) of N8 or better, 49% had N12 or better, 64% had N14 or better 93% had N18 or better (see results table below).

In this study all of the patients reviewed had uni-ocular surgery and insertion of the Tecnis Eyhance™ IOL. Mencucci et al found that the ICB00 IOL provided better spectacle independence than its pure monofocal ancestor, the ZCB00 IOL for intermediate distance⁹. It will be worth reviewing the distance and intermediate visual acuity of patients who have the ICB00 IOL implanted in both eyes as there may be an additive effect in terms of the intermediate vision. Longer follow-up will also allow for assessment of spectacle independence for intermediate tasks in particular. One prospective randomised study¹ found that the Tecnis Eyhance™ provided better results in intermediate visual outcomes without adverse effects on patients' quality of life compared with two different monofocal IOLs (Clareon monofocal (model CNA0T0) and Tecnis® monofocal 1-piece (model PCB00)). This study involved bilateral implantation, which may have an additive effect in its benefit on intermediate vision.

Several studies^10-13 have shown that the binocular uncorrected near visual acuity with the Tecnis Eyhance™ was significantly better compared to a standard monofocal IOL.

Photic phenomena and reduced contrast sensitivity are well known negative side effects of multifocal IOLs. Our study did not look at either but a recent meta- analysis of 680 eye implanted with the Tecnis Eyhance™ found that neither side effect was introduced⁴.

In this preliminary study we did not include results of patients who had macular pathology but as many patients who do not have macular pathology at the time of cataract surgery will go on to develop macular degeneration, it is interesting to know how they will fare. Venter et al¹⁴ compared the clinical outcomes of the Tecnis Eyhance™ IOL compared to the Tecnis Monofocal IOL in patients with early and intermediate age-related macular degeneration and found that both binocular intermediate and near visual acuities were significantly better in the enhanced monofocal compared to the standard monofocal. Another study¹⁵ compared the Tecnis Eyhance™ with a standard Tecnis monofocal in patient with foveal photoreceptor-preserving epiretinal membranes who underwent combined phacovitrectomy. and found the enhanced monofocal to have significantly better intermediate vision at 6 months.

The limitations of our study include its small sample size and the short follow up time. Patient satisfaction questionnaires would have given additional information including the level of spectacle independence for everyday tasks postoperatively. This would be particularly beneficial to assess in patients who in time undergo bilateral implantation.

Conclusions:

The Tecnis Eyhance™ IOL was found to be an effective IOL providing excellent distance visual acuity and in addition to this, approximately half the patients had intermediate vision of N12 or better and all patients had intermediate vision of N36 or better.

Using this IOL allows patients the advantage of being able to carry out intermediary tasks such as tablet use, reading sheet music, seeing the dashboard controls and reading price displays in supermarkets without needing reading glasses or bifocals. It is an effective treatment without the cost that multifocal IOLs bring, nor the compromise associated with both multifocal IOLs and monovision in terms of side-effects that affect the quality of vision. The complexities of ocular dominance identification, which is required pre-operatively for monovision IOLs is not required.

It will be worthwhile to assess binocular distance and intermediate visual acuity in patients who have undergone bilateral implantation, as to whether there is an additive effect in terms of intermediate vision, that may further alleviate patients’ spectacle dependence.

List of abbreviations used (if any), IOL = intraocular lens, LogMAR = Logarithm of the Minimum Angle of Resolution, DCIVA = Distance corrected intermediate visual acuity Competing interests: There is no conflict interest nor any financial disclosures.

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