Visual performance and patient satisfaction with AcrySof® IQ Vivity® IOL: Experience from a tertiary care center in central India

Abstract

Purpose:

To study the visual outcomes and patient satisfaction profile among patients post phacoemulsification with the Vivity intraocular lens (IOL) implantation.

Method:

This was a hospital-based, prospective, observational study cons isting of 64 study subjects who were followed up for 1 month to look for the objective and subjective aspects of visual outcomes of Vivity IOLs. Objective parameters included distance vision, intermediate vision, near vision, and contrast-sensitivity, whereas subjective parameters were assessed using the modified Catquest 9SF Questionnaire.

Results:

Among the total study population, 82.5% were males and 17.5% were females, the most common age group was 41–50 years. In addition, 93.6% had a distance visual acuity of 6/9 or better, 93.7% had an intermediate vision of N18 or better, whereas 50.8% had a near vision of N18 or better. Good contrast sensitivity was reported among 79.4% of subjects, and 95.2% of study subjects were comfortable with distance vision, whereas 74.6% and 22.2% were comfortable with intermediate and near vision, respectively. Only two patients complained of glare, whereas none complained of halos and starbursts. A total of 88.8% of study subjects were satisfied with their postoperative visual outcomes, whereas 87.3% were willing to Vivity IOL in the other eye or were willing to refer this IOL to others.

Conclusion:

The study demonstrated a good distance and intermediate visual acuity post-Vivity IOL implantation, whereas near activities mostly required the use of near-addition glasses, though requiring lesser near-addition power.

Cataract surgery has evolved over the years. With the newer advents in the types of intraocular lenses (IOL), optical biometers for accurate IOL power measurements, and a leap in the operating techniques plus types of equipment, cataract surgery has become more of a refractive procedure,[1] with patients demanding better and more spectacle independence post-cataract surgery. The standard time-tested monofocal IOLs provide a better distance visual outcome but are unable to provide good intermediate and near visual acuity; thus, the patient requires near visual aids post-surgery. This led to the advent of multifocal IOLs. Multifocal IOLs (bifocals) of the refractive and diffractive designs led to considerable improvement in the near vision, whereas the trifocal IOLs corrected the near, intermediate, and distance vision. However, they come at the expense of reduced contrast sensitivity and the photic phenomenon of glare, halos, and starbursts.[2] Halos are rings that appear around the light source and starbursts are glare that are observed around lights, this causes poor visual experiences and especially difficulty in driving at night. This led to the need for an IOL that provides a good distance visual acuity and a usable intermediate vision correction with a better quality of vision to enable patients to perform most of their daily routine activities without the need for visual aids. A newer category of IOL was introduced that offered an increased depth of focus across a continuous range, called the extended depth of focus (EDoF) IOLs, these newer IOL designs address some of the pitfalls associated with bifocal IOLs, such as reduced contrast sensitivity, photic phenomenon, and night vision problems.[3]

The AcrySof® IQ Vivity® (Vivity IOL) is a new non-diffractive, wavefront shaping, EDoF IOL built on the AcrySof® IQ platform by Alcon Inc., USA. The IOL is a single-piece, hydrophobic aspheric, posterior chamber IOL with ultraviolet protection and blue-light filter. It works on the principle of X-wave technology™ [Fig. 1], in which it consists of a small, 2.2-mm central 650 µm elevation that helps to stretch the wavefront creating a continuous focal range and also helps to utilize all the light energy.[4]

Figure 1.

“X-wave technology” mechanism of Vivity IOLs

The Vivity IOL received its US food and drug administration (FDA) approval in February 2020, and the Central Drug Standard Control Organization (CDSCO), India, approval was obtained in October 2021.

With a wide variety of IOLs from different manufacturers, each with a variety of working principles and claims of better visual outcomes, it becomes important for independent researchers to compare and contrast the visual outcomes and patient satisfaction profile post-IOL implantation. The purpose of the current study is to analyze the objective and subjective normative clinical outcomes for patients who underwent cataract surgery with Vivity IOL implantation.

Methods

This was a prospective, hospital-based, observational study of patients undergoing cataract surgery with the implantation of Vivity EDoF IOL during the 12 months study period.

Study design: Prospective, observational study.

Study duration: 12 months (April 2022–March 2023).

Study setting: Tertiary Care Ophthalmic Institute in central India.

Inclusion criteria

Patients with age ≥30 years who had cataracts in any eye. Patients undergoing cataract surgery with Vivity IOL. Patients giving consent for the study.

Exclusion criteria

Any systemic or ocular disease that could affect the visual outcomes. Zonular instability or dialysis. Patients with central corneal pathologies. Patients with intraoperative complications. Patient with herpetic keratitis. Patients with diagnosed amblyopia or a calculated IOL power difference of more than 3 diopters compared to the other eye. Patients not giving consent for the study.

Study protocol

All patients enrolled for the study were preoperatively assessed for vision. Slit-lamp examination was conducted by an ophthalmologist to look for a detailed anterior segment assessment, and grading of the cataract, followed by a detailed fundus examination with an indirect ophthalmoscope and ocular coherence tomography (OCT) examination to rule out any macular pathology.

The patient was counseled for cataract surgery and was explained the benefits of a premium IOL, patients were provided with the options of different IOLs and if the patient opted for Vivity IOL, the patient was enrolled in the study after obtaining informed consent.

The biometric calculation was performed using the Zeiss optical biometer IOL Master® 700, using Barret’s formula. The patients with cylindrical power above 1 diopter were planned for Toric Vivity IOL. Routine preoperative medications of moxifloxacin (0.5%) a day before the surgery were administered. Cataract surgery was performed by an experienced ophthalmologist following a routine phacoemulsification procedure using the Alcon CENTURION® Vision System, with a 2.2-mm incision. Verion image guidance was used in the case of Toric IOLs. Vivity IOL was delivered post-phacoemulsification using the Alcon IOL delivery system and was placed in the bag with proper centration.

Routine postoperative medications consisting of antibiotics (0.5% moxifloxacin) and steroids (1% prednisolone) in tapering doses, along with lubricants were administered. The patient was routinely followed up after 1 week (7–15 days); during this visit, the initial postoperative visual outcome data were collected and tabulated for analysis. The final visual outcome data were collected during the second postoperative visit of the patient (25–35 days postoperatively). The tabulated data were used for statistical analysis.

The study was conducted following the tenants of the Declaration of Helsinki, with previous approval from the Institutional Ethics Committee.

Sample size

All patients undergoing cataract surgery with the implantation of Vivity IOLs during the study period were enrolled in the study. A total of 64 eyes of 57 patients were enrolled, of which 1 patient was lost to follow-up and was excluded from the study, the effective sample size was 63. No intraoperative or postoperative complications were reported.

Study parameters

1. Postoperative vision-distant vision–using Snellen’s chart at 6 m distance

   Intermediate vision-using handheld Snellen’s chart at 66 cm distance.

   Near vision-using near-vision Snellen’s chart at 33 cm distance.

2. Contrast sensitivity–using the Pelli–Robson chart.

Study questionnaire

The cataract study questionnaire, a modified Catquest 9SF questionnaire as per the Indian scenario was used to note the subjective visual outcomes of the Vivity IOL.[5] The patients were asked about the visual comfort post-surgery and any need for visual aids at a distance, intermediate, and near vision. The incidences of photic phenomena (glare, halos, and starbursts) were also enquired. Satisfaction level post-IOL implantation, which is a subjective parameter, was also noted, as per the experience of the patient.

Statistical analysis

Data obtained were tabulated in MS Excel™ and analyzed using the IBM SPSS Software™ version 24. The objective and subjective parameters were tabulated and analyzed.

Results

In this hospital-based, observational, prospective study, of the 64 subjects enrolled, 1 was lost to follow-up and was excluded from the study. Sixteen patients were implanted with the Toric Vivity IOL. A total of 52 (82.5%) were males, whereas 11 (17.5%) were females [Table 1]. A total of 15 (23.8%) subjects enrolled and belonged to the age group of 41–50 years, whereas 13 (20.6%) subjects were above 70 years, 12 (19%) belonged to the age group of 61–70 years, and 12(19%) subjects belonged each to the age group of 51-60 years and 61-70 years, whereas 11 (17.4%) belonged to the 31–40 years age group. The mean age of the subjects was 55.03 ± 14.32 years [Table 1].

Table 1.

Demographic data of study subjects (n=63)

Gender		No.		%
Male		52		82.5
Female		11		17.5
Age group		No.		%
31–40 years		11		17.4
41–50 years		15		23.8
51–60 years		12		19
61–70 years		12		19
>70 years		13		20.6

Among the 63 eyes of 57 study subjects, 46 (73%) had a distance visual acuity of 6/6 (log MAR 0.0), whereas 13 (20.6%) had a visual acuity of 6/9 (log MAR 0.18), and 4 (6.3%) had a visual acuity of 6/12 or less (log MAR < 0.30). Among the 63 eyes, 50 (79.4%) had an intermediate visual acuity of N6-N9, whereas 9 (14.3%) had a visual acuity of N12-N18, and 4 (6.3%) had a visual acuity of N24-N36. Among the 63 eyes, 1 (1.6%) had a near visual acuity of N6-N9, whereas 31 (49.2%) had a near visual acuity of N12-N18, and 31 (49.2%) had a near visual acuity of N24-N36. A total of 50 (79.4%) study subjects had a contrast sensitivity of 2–2.15, and 13 (20.6%) had a contrast sensitivity of 1.5–2.0 on the Pelli–Robson chart [Table 2].

Table 2.

Objective visual parameters post-phacoemulsification with Vivity IOL implantation (n=63)

Post-surgery distant vision (log MAR)		7-15 days		25-35 days
6/6 (0.0)		46 (73%)		46 (73.0%)
6/9 (0.18)		10 (15.9%)		13 (20.6%)
6/12 or less (<0.30)		7 (11.1%)		4 (6.3%)
Post-surgery intermediate vision		7-15 days		25-35 days
N6-N9		45 (71.4%)		50 (79.4%)
N12-N18		12 (19.1%)		9 (14.3%)
N24-N36		6 (9.5%)		4 (6.3%)
Post-surgery near vision		7-15 days		25-35 days
N6-N9		1 (1.6%)		1 (1.6%)
N12-N18		31 (49.2%)		31 (49.2%)
N24-N36		31 (49.2%)		31 (49.2%)
Contrast sensitivity		7-15 days		25-35 days
2–2.15		50 (79.4%)		50 (79.4%)
1.5–2.0		13 (20.6%)		13 (20.6%)
<1.5		0		0

Two (3.1%) study subjects complained of intermittent glare in bright light, whereas none of the study subjects complained of halos, starbursts, or difficulty driving at night.

The subjective analysis was conducted on the patient’s experience with each eye, post-Vivity IOL implantation; thus, the total sample size (n) was 63. A total of 60 (95.2%) study subjects were always comfortable with distance vision, whereas 46 (73%) study subjects were comfortable with intermediate vision, and 14 (22.2%) patients were sometimes comfortable with near vision. Forty (6.5%) study subjects were very satisfied with visual outcomes post-surgery, whereas 25.4% were satisfied, 9.5% were neither satisfied nor dissatisfied, and 1.6% were not very satisfied with the visual outcomes post-surgery. Fifty-five (87.3%) study subjects were willing for Vivity IOL in the other eye or were willing to refer this IOL to others, whereas six patients got operated with Vivity IOL in the other eye during the study period [Table 3].

Table 3.

Subjective patient satisfaction data post phacoemulsification with Vivity IOL implantation (n=63)

Comfortable for vision		7-15 days		25-35 days
Distance
Always		59 (93.7%)		60 (95.2%)
Sometimes		4 (6.3%)		3 (4.8%)
Intermediate
Always		42 (66.7%)		46 (73.0%)
Never		5 (7.9%)		2 (3.1%)
Sometimes		16 (25.4%)		15 (23.8%)
Near
Never		49 (77.8%)		49 (77.8%)
Sometimes		14 (22.2%)		14 (22.2%)
Satisfaction		7-15 days		25-35 days
Very satisfied		40 (63.4%)		40 (63.5%)
Satisfied		16 (25.4%)		16 (25.4%)
Neither satisfied nor dissatisfied		6 (9.5%)		6 (9.5%)
Not satisfied		1 (1.6%)		1 (1.6%)
Visual disturbances		7-15 days		25-35 days
Halos		0		0
Glare		3 (4.7%)		2 (3.1%)
Starbursts		0		0
Difficulty in driving at night		0		0
Preference for Vivity EDoF IOL		7-15 days		25-35 days
Yes		55 (87.3%)		55 (87.3%)
No		8 (12.7%)		8 (12.7%)

Discussion

This was a prospective, observational study with a 1-month postoperative follow-up in 63 patients with cataract surgery with the EDOF AcrySof® IQ Vivity® IOL implantation. The 63 study subjects comprised 52 males and 11 females. The study subjects were mostly of the age group of 41–50 years with close distribution in all the age groups, the mean age was 55 years, the study covers all the age groups with almost equitable distribution in the age groups, thus avoiding a confounding bias due to age.

On 1-month follow-up, 73% of the study subjects had a distant vision of 6/6, whereas 20.6% had a vision of 6/9, this result shows a good distance visual acuity in study subjects with Vivity IOL. On subjective analysis, 95.2% of the patients were comfortable with their distant vision without any spectacle correction. This result correlates with the study conducted by Arrigo et al.[6] and van Amelsfort et al.[7] who also showed good distance visual outcomes in patients postoperatively.

On 1-month follow-up, 93.7% of the study subjects had an intermediate vision of N18 or better, whereas subjectively, 96.8% of the patients were comfortable with their postoperative intermediate vision, with 73% reported to perform all intermediate work without the aid of spectacles, whereas 23.8% reported a minimal need for spectacles for intermediate work. Similar patient experiences were reported in a study conducted by Arrigo et al.[6] and Cummings et al.[8]

On a 1-month follow-up, 50.8% of the study subjects had a near vision of N18 or better, whereas subjectively, 49.2% of study subjects reported the need for spectacles for most of the near work. This result concurs with the results of the study conducted by van Amelsfort et al.,[7] in which they reported that 38% of study subjects required glass prescription for near work. Arrigo et al.[6] reported a need for approximately +1.00 D near addition in postoperative patients, provided good near-visual acuity.

There was good contrast sensitivity perception in the study subjects post-Vivity IOL implantation. Only two patients complained of intermittent glare post-surgery, whereas none complained of halos, starbursts, or difficulty in driving at night. Arrigo et al.,[6] in their study, reported the incidence of halos and glares, which were well tolerated by the patients. Cumming[8] et al. reported incidences of the photic phenomenon with Vivity IOLs, which were comparable to the use of monofocal IOLs. van Amelsfort et al.[7] reported a 9% incidence of glare and halos, whereas none of them reported starbursts post-surgery. Of the total study subjects, 88.8% were satisfied with the visual outcomes of the IOL, whereas 87.3% were willing to Vivity IOL in the other eye or were willing to refer the IOL to others.

The visual outcomes and the subjective patient satisfaction did not significantly change between the first postoperative visit at 1 week and the second visit at 1 month, thus establishing that patients gain most of the visual outcomes by the first week, although long-term studies can help better understand the biocompatibility of the Vivity IOL and the rate of posterior subcapsular growth. In this study, we also included two patients with mild-to-moderate glaucoma, who underwent phacoemulsification with Vivity IOL implantation and reported good postoperative visual outcomes and patient satisfaction, though we cannot conclude how Vivity IOLs would perform in patients with various ocular comorbidities. A further follow-up study with larger sample size, defocus curve analysis, and performance of Vivity IOL in ocular comorbidities would be conducted for better analysis of the IOL.

Conclusion

The study demonstrates a good distance and intermediate visual acuity in patients with Vivity IOL implantation. Most patients required spectacle correction for near vision, though the near addition was less than the monofocals. Subjectively analyzed patients were satisfied with their visual outcomes post-surgery, with minimal complaints of the photic phenomenon. This study concludes that Vivity IOL provides a good extended range of vision, with good distance and intermediate vision, which are useful for the daily activities of the patients and render the patient a useful glass-free vision for most of the routine work. However, patients required near addition spectacle correction while reading books or fine work.

Financial support and sponsorship: Nil.

Conflicts of interest: There are no conflicts of interest.