Journal of Refractive Surgery

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Binocular and Monocular Implantation of Small-Aperture Intraocular Lenses in Cataract Surgery

H. Burkhard Dick, MD, PhD; Matthias Elling, MD, FEBO; Tim Schultz, MD, FEBO

Abstract

PURPOSE:

To compare the clinical outcomes with the extended depth of focus small-aperture intraocular lens (IOL) (IC-8; AcuFocus, Irvine, CA) for presbyopia compensation when implanted monocularly or binocularly.

METHODS:

Visual outcomes, defocus curve, patient satisfaction, and visual symptoms during a 6-month follow-up were evaluated in 11 patients (contralateral group) implanted monocularly with this IOL and with an aspheric monofocal IOL in the fellow eye (myopic target) and 6 patients (bilateral group) implanted bilaterally with the IC-8 IOL (dominant eye with plano target, fellow eye with myopic target).

RESULTS:

Bilateral implantation of the IC-8 IOL resulted in an extended range of focus, with better intermediate and near vision. Monocular implantation of the IC-8 IOL resulted in a significantly higher overall satisfaction score and lower halo score.

CONCLUSIONS:

Bilateral implantation of the IC-8 IOL resulted in an extended range of focus, with better intermediate and near vision than monocular implantation of this IOL.

[J Refract Surg. 2018;34(9):629–631.]

Abstract

PURPOSE:

To compare the clinical outcomes with the extended depth of focus small-aperture intraocular lens (IOL) (IC-8; AcuFocus, Irvine, CA) for presbyopia compensation when implanted monocularly or binocularly.

METHODS:

Visual outcomes, defocus curve, patient satisfaction, and visual symptoms during a 6-month follow-up were evaluated in 11 patients (contralateral group) implanted monocularly with this IOL and with an aspheric monofocal IOL in the fellow eye (myopic target) and 6 patients (bilateral group) implanted bilaterally with the IC-8 IOL (dominant eye with plano target, fellow eye with myopic target).

RESULTS:

Bilateral implantation of the IC-8 IOL resulted in an extended range of focus, with better intermediate and near vision. Monocular implantation of the IC-8 IOL resulted in a significantly higher overall satisfaction score and lower halo score.

CONCLUSIONS:

Bilateral implantation of the IC-8 IOL resulted in an extended range of focus, with better intermediate and near vision than monocular implantation of this IOL.

[J Refract Surg. 2018;34(9):629–631.]

A new intraocular lens (IOL) based on the concept of extended depth of focus using small-aperture optics has been recently released, the IC-8 IOL (AcuFocus, Irvine, CA).1 This concept is adapted from a similar technology implanted monocularly in the cornea for presbyopia correction, called the KAMRA inlay (AcuFocus). This corneal inlay has been demonstrated to be a safe and effective option for presbyopia compensation,2 with good long-term outcomes.3 Studies have demonstrated that the small-aperture IC-8 IOL is able to provide good postoperative vision, safety, patient satisfaction, and tolerance to residual astigmatism when implanted monocularly.1,4,5 The aim of this prospective case series was to evaluate the clinical outcomes obtained with the extended depth of focus small-aperture IC-8 IOL when implanted monocularly or binocularly.

Case Report

This is a report on a single-site series of patients (University of Bochum, Department of Ophthalmology, Bochum, Germany). Data from 11 patients (11 eyes, contralateral group) implanted monocularly with the IC-8 IOL and with an aspheric monofocal IOL in the fellow eye (target −0.50 to −0.75 diopters [D]) and 6 patients (12 eyes, bilateral group) implanted bilaterally with the IC-8 IOL (dominant eye with plano target and the other with myopic target) were prospectively evaluated. Inclusion and exclusion criteria and preoperative examinations were previously described.4

At 1, 3, and 6 months postoperatively, monocular and binocular uncorrected (UDVA), corrected (CDVA), and target-corrected (TCDVA at 4 m) distance, uncorrected (UIVA), distance-corrected (DCIVA), and target-corrected (TCIVA at 67 cm) intermediate, and uncorrected (UNVA), distance-corrected (DCNVA), and target-corrected (TCNVA at 40 cm) near visual acuities were measured. At 3 months postoperatively, the subjective questionnaire was completed.

Figures 12 and Table A (available in the online version of this article) summarize the postoperative binocular visual outcomes obtained in both groups. Significantly better binocular UIVA (P = .029), UNVA (P = .049), DCIVA (P = .043), and DCNVA (P = .038) were found in the bilateral group compared to the contralateral group at 3 months after surgery. The same trend but without significance was observed at 6 months after surgery for near visual acuities (P ≥ .143). No significant differences in postoperative refraction were found between the monofocal eye from the contralateral group and the myopic or plano-target IC-8 eye from the bilateral group (P = .054). The defocus curve revealed a higher visual acuity at negative defocus levels in the bilateral group but both curves showed the same peak at 0.00 D (Figure 3). Specifically, better distance-corrected visual acuities were observed for defocus levels equivalent to intermediate and near vision, although differences did not reach statistical significance (P > .05).

Binocular (A) uncorrected distance (UDVA), (B) intermediate (UIVA), and (C) near (UNVA) visual acuities 6 months after surgery (mean ± standard deviation) in the contralateral and bilateral groups.

Figure 1.

Binocular (A) uncorrected distance (UDVA), (B) intermediate (UIVA), and (C) near (UNVA) visual acuities 6 months after surgery (mean ± standard deviation) in the contralateral and bilateral groups.

Monocular (A) uncorrected distance (UDVA), (B) intermediate (UIVA), and (C) near (UNVA) visual acuities 6 months after surgery (mean ± standard deviation) in the contralateral and bilateral groups.

Figure 2.

Monocular (A) uncorrected distance (UDVA), (B) intermediate (UIVA), and (C) near (UNVA) visual acuities 6 months after surgery (mean ± standard deviation) in the contralateral and bilateral groups.

Summary of the Postoperative Binocular Visual Outcomes in the Contralateral and Bilateral Groupsa

Table A:

Summary of the Postoperative Binocular Visual Outcomes in the Contralateral and Bilateral Groups

Mean 6-month postoperative binocular defocus curve in the contralateral and bilateral groups. VA = visual acuity; D = diopters

Figure 3.

Mean 6-month postoperative binocular defocus curve in the contralateral and bilateral groups. VA = visual acuity; D = diopters

Lower patient satisfaction scores were reported in the bilateral group, but differences did not reach statistical significance (P ≥ .068). Only a significantly better overall satisfaction score was obtained in the contralateral group compared to the bilateral group (P = .048). All patients in the contralateral group would undergo the surgery again, compared to 83% of patients in the bilateral group (P = .205). Concerning symptomatology, significantly higher scores were found in the bilateral group for symptoms of halos (P = .001) (Tables BC, available in the online version of this article).

Satisfaction Scores 3 Months Postoperativelya,b

Table B:

Satisfaction Scores 3 Months Postoperatively,

Visual Symptom Severity Scores 3 Months Postoperative

Table C:

Visual Symptom Severity Scores 3 Months Postoperative

No serious adverse event occurred in either group. There were 5 ocular adverse events, including 3 eyes with an IC-8 IOL (elevated intraocular pressure requiring treatment, fibrin reaction, and blepharitis) and 2 cases of elevated intraocular pressure requiring treatment in eyes with a monofocal IOL. All adverse events were categorized as not related to the device.

Discussion

In the current case series, we confirm the good performance of small-aperture IOLs for the compensation of presbyopia using two different approaches of implantation: unilateral and bilateral. In both cases, a micro-monovision was induced to optimize the extension of the depth of focus, as in previous series.1,4,5 Our results are consistent with the outcomes reported in previous studies evaluating the performance of the same implant.1,4 In comparison with the results reported for other extended depth of focus IOLs, the IC-8 IOL showed a similar visual performance for distance and intermediate vision, but somewhat better visual acuities for near.6,7

We present the first results including patients implanted bilaterally with the small-aperture IOL. In comparison with the contralateral approach, the bilateral implantation of the small-aperture IOL provided improved intermediate and near binocular visual outcomes, without differences in terms of refractive predictability. The combination of the small-aperture optical effect and the micro-monovision approach allows an improvement of visual performance for a greater variety of vergence demands. This was also observed in the defocus curve analysis, with higher curves while maintaining the same peak in eyes implanted bilaterally with the IC-8 IOL. The level of near visual acuity achieved with the bilateral approach of the IC-8 IOL was comparable to that reported with different multifocal IOLs.8

Patient satisfaction was high in eyes with monolateral implantation, with minimal incidence of disturbing photic phenomena. However, lower overall satisfaction and higher scores for halos were found in eyes with bilateral implantation of the small-aperture IOL. This finding may be in relation to the larger preoperative pupil size in the bilateral group. A previous study showed that visual symptoms after monocular IC-8 IOL implantation were significantly related to pupil size and that higher levels of halos were reported by patients with mesopic pupils larger than 5.6 mm.4 Optical simulations demonstrated that the advantages of small-aperture optics implants may be reduced in cases of large physiological pupil diameters, with a drop of the defocus range when light passes outside the small-aperture optics diameter.9

Pseudophakic monovision with monofocal lenses is an effective method for presbyopia correction with high spectacle independence and minimal photic phenomena.10 Future studies are necessary to compare the outcomes of monovision with monolateral or bilateral IC-8 IOL implantations in terms of stereoacuity, contrast sensitivity, and patient satisfaction.

This case series demonstrates that bilateral implantation of the small-aperture IC-8 IOL results in an extended range of focus, with better near and intermediate vision than after monocular implantation and similar potential complications4 compared to other premium IOLs. However, patient satisfaction was highest in the contralateral group. A limitation of this pilot evaluation is the small sample size. Additional studies with more patients and longer follow-up are needed to make any inferences regarding visual performance after bilateral small-aperture IOL implantation.

References

  1. Grabner G, Ang RE, Vilupuru S. The small-aperture IC-8 intraocular lens: a new concept for added depth of focus in cataract patients. Am J Ophthalmol. 2015;160:1176–1184. doi:10.1016/j.ajo.2015.08.017 [CrossRef]
  2. Waring GO 4th, . Correction of presbyopia with a small aperture corneal inlay. J Refract Surg. 2011;27:842–845. doi:10.3928/1081597X-20111005-04 [CrossRef]
  3. Dexl AK, Jell G, Strohmaier C, et al. Long-term outcomes after monocular corneal inlay implantation for the surgical compensation of presbyopia. J Cataract Refract Surg. 2015;41:566–575. doi:10.1016/j.jcrs.2014.05.051 [CrossRef]
  4. Dick HB, Piovella M, Vukich J, Vilupuru S, Lin LClinical Investigators. Prospective multicenter trial of a small-aperture intraocular lens in cataract surgery. J Cataract Refract Surg. 2017;43:956–968. doi:10.1016/j.jcrs.2017.04.038 [CrossRef]
  5. Eppig T, Spira C, Seitz B, Szentmáry N, Langenbucher A. A comparison of small aperture implants providing increased depth of focus in pseudophakic eyes. Z Med Phys. 2016;26:159–167. doi:10.1016/j.zemedi.2016.03.003 [CrossRef]
  6. Cochener BConcerto Study Group. Clinical outcomes of a new extended range of vision intraocular lens: International Multicenter Concerto Study. J Cataract Refract Surg. 2016;42:1268–1275. doi:10.1016/j.jcrs.2016.06.033 [CrossRef]
  7. Pedrotti E, Bruni E, Bonacci E, Badalamenti R, Mastropasqua R, Marchini G. Comparative analysis of the clinical outcomes with a monofocal and an extended range of vision intraocular lens. J Refract Surg. 2016; 32:436–442. doi:10.3928/1081597X-20160428-06 [CrossRef]
  8. Cardona G, Vega F, Gil MA, Varón C, Buil JA, Millán MS. Visual acuity and image quality in 5 diffractive intraocular lenses. Eur J Ophthalmol. 2018;28:36–41. doi:10.5301/ejo.5000994 [CrossRef]
  9. Eppig T, Spira C, Seitz B, Szentmáry N, Langenbucher A. A comparison of small aperture implants providing increased depth of focus in pseudophakic eyes. Z Med Phys. 2016;26:159–167. doi:10.1016/j.zemedi.2016.03.003 [CrossRef]
  10. Labiris G, Toli A, Perente A, Ntonti P, Kozobolis VP. A systematic review of pseudophakic monovision for presbyopia correction. Int J Ophthalmol. 2017;10:992–1000.

Summary of the Postoperative Binocular Visual Outcomes in the Contralateral and Bilateral Groupsa

VAContralateral GroupBilateral GroupPb,c


1 Month (n = 11)3 Months (n = 11)6 Months (n = 11)1 Month (n = 6)3 Months (n = 6)6 Months (n = 6)
UDVA0.05 ± 0.140.02 ± 0.11−0.02 ± 0.090.06 ± 0.050.04 ± 0.070.06 ± 0.05.072
UIVA0.06 ± 0.030.03 ± 0.060.00 ± 0.080.00 ± 0.07−0.05 ± 0.070.00 ± 0.16.017
UNVA0.22 ± 0.090.17 ± 0.090.15 ± 0.120.13 ± 0.110.06 ± 0.090.04 ± 0.11.003
CDVA−0.05 ± 0.06−0.05 ± 0.09−0.08 ± 0.07−0.01 ± 0.05−0.02 ± 0.08−0.02 ± 0.09.071
DCIVA0.03 ± 0.060.03 ± 0.070.05 ± 0.080.04 ± 0.04−0.03 ± 0.040.04 ± 0.07.127
DCNVA0.23 ± 0.090.22 ± 0.100.24 ± 0.110.24 ± 0.060.12 ± 0.040.18 ± 0.12.086
TCDVA−0.01 ± 0.08−0.05 ± 0.06−0.07 ± 0.080.07 ± 0.100.02 ± 0.120.00 ± 0.06.006
TCIVA0.01 ± 0.070.00 ± 0.09−0.02 ± 0.07−0.01 ± 0.03−0.07 ± 0.05−0.03 ± 0.08.198
TCNVA0.13 ± 0.070.13 ± 0.100.12 ± 0.110.10 ± 0.050.07 ± 0.070.10 ± 0.13.104

Satisfaction Scores 3 Months Postoperativelya,b

SatisfactionContralateral GroupBilateral GroupP
Overall4.5 ± 0.73.0 ± 1.7.048
Distance vision4.7 ± 0.53.5 ± 1.6.068
Intermediate vision4.6 ± 0.53.8 ± 1.5.173
Near vision3.9 ± 1.13.7 ± 1.5.829

Visual Symptom Severity Scores 3 Months Postoperative

Visual SymptomContralateral GroupBilateral GroupP
Blurry vision1.6 ± 1.31.5 ± 1.4.836
Fluctuating vision1.0 ± 1.31.7 ± 1.4.333
Glare1.3 ± 1.92.8 ± 1.6.115
Halo0.5 ± 1.23.7 ± 0.5.001
Double vision0.1 ± 0.30.7 + 1.6.590
Ghosting0.0 ± 0.00.0 ± 0.01.000
Authors

From University of Bochum, Department of Ophthalmology, Bochum, Germany.

Dr. Dick is a consultant and physician advisor for AcuFocus. The remaining authors have no financial or proprietary interest in the materials presented herein.

AUTHOR CONTRIBUTIONS

Study concept and design (HBD, ME, TS); data collection (HBD, ME, TS); analysis and interpretation of data (HBD); writing the manuscript (HBD, ME, TS); critical revision of the manuscript (HBD, ME, TS); statistical expertise (HBD, ME, TS); supervision (HBD)

Correspondence: H. Burkhard Dick, MD, PhD, Ruhr University of Bochum, Department of Ophthalmology, In der Schornau 23–25, Bochum, NRW 44892, Germany. E-mail: burkhard.dick@kk-bochum.de

Received: March 01, 2018
Accepted: July 09, 2018

10.3928/1081597X-20180716-02

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