Clinical Visual Outcomes Over a Range of Vision Following Cataract Surgery with Bilateral Implantation of a Hybrid Multifocal and Extended Depth of Focus Intraocular Lens

doi:10.21203/rs.3.rs-3308228/v1

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Research Article

Clinical Visual Outcomes Over a Range of Vision Following Cataract Surgery with Bilateral Implantation of a Hybrid Multifocal and Extended Depth of Focus Intraocular Lens

https://doi.org/10.21203/rs.3.rs-3308228/v1

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Background:

To evaluate binocular visual outcomes, with emphasis on near intermediate vision at 50 cm, in patients undergoing bilateral cataract surgery with implantation of the Synergy hybrid intraocular lens with multifocal and extended depth of focus diffractive optics.

Methods:

A chart review was conducted of all patients undergoing phacoemulsification by a single surgeon with bilateral implantation of a Synergy IOL from August 2021 through March 2023. Primary endpoints were Uncorrected Distance Visual Acuity (UDVA), Uncorrected and Distance-Corrected Near Visual Acuity (UNVA and DCNVA, respectively) at 33 cm, Corrected Distance Visual Acuity (CDVA), and Distance-Corrected Intermediate Visual Acuity at 50 and 66 cm (DCIVA-50 and DCIVA-66, respectively).

Results:

Eighty-six eyes of 43 patients (26 or 60% female, mean age 70 years) were included with a mean followup of 42 days. Mean values for binocular visual acuity were as follows: UDVA 0.01 ± 0.05 logarithm of the minimum angle of resolution (logMAR), UNVA 0.01 ± 0.03 logMAR, CDVA 0.00 ± 0.00 logMAR with a mean spherical equivalent of 0.04 diopters ± 0.22, DCNVA 0.00 ± 0.00 logMAR, DCIVA-50 0.04 ± 0.17 logMAR, and DCIVA-66 0.12 ± 0.07 logMAR.

Conclusions:

The Synergy hybrid IOL achieved excellent visual acuity at a distance of 50 cm, corresponding to many intermediate tasks, as well as distance, intermediate, and near visual acuity at traditionally measured ranges.

Synergy

multifocal

EDOF

hybrid IOL

Presbyopia correcting intraocular lenses (IOL) continue to advance in design. While refractive technology including extended depth of focus and bifocal designs are being offered, diffractive technology remains a predominant means to offer a full range of vision to patients undergoing cataract surgery and who seek independence from corrective lens wear. The emergence of diffractive extended depth of focus (EDOF) technology has been shown to improve the depth of focus curves and subsequent continuous range of distance through intermediate vision.^1,2 The Tecnis Synergy IOL (Johnson & Johnson Vision) is designed as a hybrid lens that combines both EDOF as well as multifocal diffractive optics to provide a full range of vision.^3–5 The IOL is available in both standard and toric versions. Several published studies have demonstrated that it performs well for distance, intermediate, and near vision at various ranges.^6–13 These studies have reported clinical outcomes from bilateral implantation of this lens in patients at near focal points of 33, 40, 66, and 80 cm. This author’s experience with the Tecnis Symfony EDOF IOL (Johnson & Johson)¹⁴ and its clinical results has suggested the importance of not only measuring a traditional near point of focus of 33 cm and a traditional optical intermediate focal point of 66 cm, but also a practical close intermediate focal point of 50 cm corresponding to computer use encountered in patients’ daily lives. This study was therefore designed to evaluate binocular outcomes of distance, far intermediate, near intermediate, and near vision in eyes bilaterally implanted with the Tecnis Synergy IOL by a single surgeon in a routine clinical setting.

A retrospective chart review was conducted of all patients undergoing phacoemulsification by a single surgeon (RTP) with bilateral implantation of a Tecnis Synergy IOL (DFR00V) or Tecnis Synergy Toric IOL (DFW150, DFW225, DFW300, and DFW375) from August 2021 through March 2023. Exclusion criteria included prior history of keratorefractive surgery, phacoemulsification combined with other anterior segment surgeries, lack of followup beyond 21 days postoperatively, concurrent ocular conditions limiting best corrected distance visual acuity to less than or equal to 20/30 Snellen [0.18 logarithm of the minimal angle of resolution (logMAR)] in either eye, or development of visually significant posterior capsular opacification (PCO) requiring YAG laser capsulotomy within 3 months of phacoemulsification. Institutional Review Board approval was obtained by the Houston Methodist Research Institute, Houston, TX. Phacoemulsification was performed using a standard microinvasive cataract surgery technique.¹⁵ Both manual as well as femtosecond laser-assisted cataract surgery (FLACS) cases were included.

Visual acuity was reported at the first postoperative visit after phacoemulsification when eyes were considered stable (no concurrent postoperative ocular conditions affecting visual acuity including unresolved iritis, cystoid macular edema, and keratitis sicca). Near visual acuity was measured using a lighted card on a phoropter rod with the patient’s distance refraction placed in the phoropter.

Primary endpoints were Uncorrected Distance Visual Acuity (UDVA), Uncorrected Near Visual Acuity (UNVA), Corrected Distance Visual Acuity (CDVA), Distance-Corrected Near Visual Acuity at 33 cm (DCNVA), and Distance-Corrected Intermediate Visual Acuity at 50 and 66 cm (DCIVA-50 and DCIVA-66, respectively). These distances were based on the average focal distance to laptop and desktop computer screen monitors and reading materials per patient preferences, as well as the bench optical properties of the Synergy IOL.³ All measurements were binocular.

Statistical Analysis

Data analysis was performed using Microsoft Excel for Microsoft 365 (Version 2306 Build 16.0.16529.20164, Microsoft Inc, WA). Snellen visual acuities were converted to logMAR for calculation of mean and standard deviation values. Statistical significance was performed with two-tailed T-test.

A total of 86 eyes of 43 patients were identified that met inclusion and exclusion criteria.

Eighty-two (95%) of eyes underwent FLACS. Fifty-eight eyes (67%) were implanted with a Synergy IOL, and the remaining 28 eyes with a Synergy Toric IOL. Mean age of patients was 70 ± 5.8 years (range 54–82). Mean followup period was 42 ± 18 days (range 23–100; Table 1). Mean preoperative CDVA was 0.06 ± 0.07 logMAR with a mean spherical equivalent refraction of -1.47 ± 3.39 diopters. Mean postoperative CDVA improved to 0.00 ± 0.00 logMAR (p < 0.0001) with an improvement in postoperative spherical equivalent refraction to 0.04 ± 0.22 diopters (P < 0.0001). There was also a significant improvement from the preoperative CDVA to the postoperative UDVA of 0.01 ± 0.05 logMAR (p < 0.001). Mean values for postoperative UDVA, UNVA, CDVA, DCNVA, DCIVA-50, and DCIVA-66 are reported in Table 1. All patients achieved a binocular CDVA 20/20 or better (1.0 logMAR), binocular DCNVA of 20/20 or better (1.0 logMAR), binocular DCIVA-50 of 20/25 (0.1 logMAR) or better, and binocular DCIVA-66 of 20/40 (0.30 logMAR) or better.

Table 1

Mean Binocular Outcomes
	Mean Values	Standard Deviation	SD Range Low	SD Range High
Ave Days Postop	42	18	24	60
LogMAR UDVA	0.01	0.05	-0.04	0.05
Snellen UDVA (20/-)	20.23		18.22	22.47
LogMAR UNVA	0.01	0.03	-0.02	0.04
Snellen UNVA (20/-)	20.40		18.91	22.01
LogMAR CDVA	0.00	0.00	0.00	0.00
Snellen CDVA (20/-)	20.00		20.00	20.00
LogMAR DCNVA	0.00	0.00	0.00	0.00
Snellen DCNVA (20/-)	20.00		20.00	20.00
LogMAR DCIVA-50	0.02	0.04	-0.02	0.06
Snellen DCIVA-50 (20/-)	20.96		19.14	22.95
LogMAR DCIVA-66	0.12	0.07	0.05	0.19
Snellen DCIVA-66	26.28		22.48	30.73
UDVA = uncorrected distance visual acuity
UNVA = uncorrected near visual acuity
CDVA = corrected distance visual acuity
DCNVA = distance corrected near visual acuity
DCIVA-50 = distance corrected intermediate visual acuity at 50 cm
DCIVA-66 = distance corrected intermediate visual acuity at 66 cm
SD = standard deviation
All distances measured in centimeters (cm)

The Synergy IOL employs a hybrid technology that provides both multifocal and EDOF diffractive optics. Theoretically and clinically this range should be more complete than traditional trifocal or EDOF-only technologies. Benchmark testing of this lens suggests that it can achieve a high level of visual acuity over a range of vision.³ To achieve a high quality of visual functioning over a range of vision, the optics of the Synergy IOL, similar to its predecessor EDOF-only Symfony IOL, correct for different types of aberration, including chromatic and spherical, providing an extremely high peak in its defocus curve.⁶ The clinical trials used for FDA approval for this lens reported results of monocular and binocular acuity at 40 cm (primary endpoint), as well as 33 and 66 cm, in addition to distance (secondary endpoints). Other studies have evaluated two and up to three near focal lengths. This study included an intermediate target of 50 cm instead of 40 cm, which the study author’s clinical experience has been more representative of required distance for intermediate vision tasks, especially in the use of a laptop computer or desktop monitor in the daily lives of many patients.

This study demonstrated that patients achieved an excellent level of DCIVA at 50 cm, along with excellent near, distance, and traditional 66 cm intermediate vision as shown in past studies. The FDA clinical trial results measured near and intermediate visual acuity up to the 20/40 level—beyond that, eyes were grouped together. The author’s experience is consistent with 20/40 (0.30 logMAR), or J3 on a near card, as a suitable target size of print to satisfy most daily intermediate tasks including computer screen work.

This study is limited by its retrospective nature and the lack of a control group. All surgeries, however, were performed by one surgeon and techniques for measuring visual outcomes in the clinic were standardized between the surgeon and the chief technician performing visual and refractive assessments. As such, it is felt that the retrospective design does not significantly impact the nature of visual outcomes reported here. One limitation of this study is that the use of a near acuity card in ideal lighting conditions may overestimate outcomes in patients who are subject to extended periods of reading or for reading in non-ideal conditions. This method of testing of near vision, however, is consistent with that employed by most clinicians when measuring patient outcomes in a normal clinical setting. Furthermore, the Synergy IOL has demonstrated that, with similar visual acuity outcomes as seen in this study, good real world reading outcomes are experienced.¹⁶

This study was not designed to capture side effects such as positive dysphotopsias or overall satisfaction rates of patients undergoing phacoemulsification with the Synergy IOL since detailed questionnaires are not routinely administered in our setting. Nevertheless, a review of all clinic notes revealed that, even though some patients did report glare or haloes on their final postop visit, no patient was dissatisfied with their IOL or required additional followup visits to manage persistent dysphotopsias. The Synergy IOL is designed with a proprietary violet light-filtering chromophore that reduces transmittance of violet wavelengths of light, which may contribute to an improved rate of dysphotopsias compared to similar IOLs without this reduction in transmission of shorter wavelength violet light.¹⁷

This study demonstrates that the Synergy IOL achieves an excellent level of intermediate visual acuity at a distance of 50 cm, corresponding to many intermediate tasks, as well as distance, intermediate, and near visual acuity at traditionally measured ranges.

DATA AVAILABILITY

The Excel spreadsheet including data and table used to support the findings of this study are available from the corresponding author upon request.

ACKNOWLEDGEMENTS

The author would like to acknowledge Cynthia Pratt for her assistance in data collection.

Ethics approval and consent to participate: This retrospective study is IRB approved and requirement for informed consent is waived. All experimental protocols were approved by the Houston Methodist Research Institute Institutional Review Board. All methods were carried out in accordance with relevant guidelines and regulations.

Consent for publication: I consent to publication of this submission.

Availability of data and materials: The Excel spreadsheet including data and table used to support the findings of this study are available from the corresponding author upon request.

Competing interests: The author has the following financial disclosures: Consultant and Speaker’s bureau: Johnson and Johnson Vision, Bausch & Lomb.

Funding: The author received no funding for this study.

Author’s contributions: Rahul T Pandit, MD was responsible for the conception, design, data acquisition, analysis, interpretation, manuscript writing, and submission of the work.

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Competing interest reported. The author RTP is a consultant and on the speaker’s bureau for Johnson and Johnson Vision. The author received no financial or other support from Johnson and Johnson Vision for this study.

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Clinical Visual Outcomes Over a Range of Vision Following Cataract Surgery with Bilateral Implantation of a Hybrid Multifocal and Extended Depth of Focus Intraocular Lens

Status:

Version 1

Abstract

Background:

Methods:

Results:

Conclusions:

INTRODUCTION

PATIENTS AND METHODS

Statistical Analysis

RESULTS

DISCUSSION

CONCLUSION

Declarations

References

Additional Declarations

Status:

Version 1