Visual outcomes and patient satisfaction after bilateral implantation of a new trifocal diffractive intraocular lens

Almulhim, Abdulmohsen; Alarfaj, Khalid; AlTaisan, Abdulaziz; Alromaih, Arwa Z.; Aldawod, Razan A.

doi:10.1016/j.sjopt.2018.08.004

Cited by 8 publications

(12 citation statements)

References 23 publications

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“…A common feature of multifocal 5 and trifocal 17e19,43,44 IOLs is the increased incidence of visual disturbances, which consist of photic phenomena such as starbursts, halos, or glare. 45 Recipients of diffractive trifocal IOLs have reported these photic phenomena. 17e19, 45 In the current study, visual disturbances were assessed using the QUVID questionnaire developed and validated by Alcon.…”

Section: Discussionmentioning

confidence: 96%

“…45 Recipients of diffractive trifocal IOLs have reported these photic phenomena. 17e19, 45 In the current study, visual disturbances were assessed using the QUVID questionnaire developed and validated by Alcon.…”

Section: Discussionmentioning

confidence: 96%

“…A reduction in TFNT00 recipients experiencing severe halos and glare between months 1 and 6 was observed, as is expected over time. 44,45,47 Visual disturbances are a common source of patient dissatisfaction with, 48 and are a reason for explantation of, multifocal IOLs. 49 Therefore, when determining the prevalence of visual disturbances, it is also important to assess the patients' perspective regarding how much they are bothered by the presence of such photic phenomena.…”

Section: Discussionmentioning

confidence: 99%

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Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens

et al. 2021

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To evaluate the effectiveness and safety of a trifocal intraocular lens (IOL), the TFNT00 (Alcon, Fort Worth, TX), versus a monofocal IOL, the SN60AT (Alcon).Design: Food and Drug Administrationeapproved, prospective, multicenter, nonrandomized, parallel-group, assessor-masked, confirmatory trial.Participants: Patients enrolled were 22 years of age or older with a diagnosis of bilateral cataract with planned removal by phacoemulsification with a clear corneal incision.Methods: Consented participants selected their preferred IOL, which was implanted sequentially into each eye of patients meeting eligibility criteria.Main Outcome Measures: The coprimary effectiveness outcomes were mean photopic monocular bestcorrected distance visual acuity (BCDVA; 4 m) and distance-corrected near visual acuity (DCNVA; 40 cm) at 6 months after surgery. Secondary effectiveness outcomes included mean monocular distance-corrected intermediate visual acuity (DCIVA; 66 cm) and proportion of participants responding "never" to question 1 of the Intraocular Lens Satisfaction questionnaire (regarding frequency of spectacle use in the past 7 days). Safety outcomes included frequency of "severe" and "most bothersome" visual disturbances.Results: Two hundred forty-three patients underwent cataract surgery with bilateral implantation of the TFNT00 (n ¼ 129) or SN60AT (n ¼ 114) and were followed up for 6 months. Noninferiority of TFNT00 to SN60AT in mean photopic monocular BCDVA (95% upper confidence limit of the difference was <0.1 logarithm of the minimum angle of resolution [logMAR] margin), and superiority in mean photopic monocular DCNVA (difference of 0.42 logMAR; P < 0.001) and DCIVA (difference of 0.26 logMAR; P < 0.001) were demonstrated. The proportion of patients never requiring glasses overall was superior for TFNT00 versus SN60AT (80.5% and 8.2%, respectively). Starbursts, halos, and glare were the most frequently rated severe symptoms with TFNT00; however, less than 5% of patients were very bothered at month 6.Conclusions: The TFNT00 exhibited superior monocular DCNVA and DCIVA to a spherical monofocal IOL, with comparable monocular BCDVA. Binocular visual acuity was 20/25 or better for distance to near (þ0.5 D to e2.5 D), resulting in high levels of spectacle independence. Less than 5% of patients were very bothered by the photic visual disturbances associated with the TFNT00 at 6 months after surgery.

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Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

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Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens

et al. 2021

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“…31 Further studies would be needed to assess the perception of additional visual disturbances associated with diffractive multifocal IOLs, such as glare and starbursts, which would help further characterize the quality of vision following TFNT00 implantation. 54 Additionally, objective testing methods using straylight meters, halometry, or computer-based simulators could be used to capture supportive quantitative metrics. 55 Limitations of the present study include a relatively short follow-up period of 3 months and the lack of a comparator IOL.…”

Section: Discussionmentioning

confidence: 99%

Clinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population

Dandapani¹,

Vasavada²,

Padmanabhan³

et al. 2021

OPTH

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Purpose: To evaluate the effectiveness and safety of a presbyopia-correcting trifocal intraocular lens (IOL), AcrySof ® IQ PanOptix ® (TFNT00), in an Indian population. Patients and Methods: This prospective, multicenter, observational, single-arm, postmarketing study included 67 patients undergoing cataract surgery with bilateral implantation of TFNT00 across five Indian sites. Postoperative outcomes were assessed at 3 months after second eye surgery. Effectiveness outcomes included: mean binocular and monocular visual acuity (VA) at distance (4 m), intermediate (60 cm), and near (40 cm); binocular defocus curve; manifest refraction; and subjective symptom questionnaire evaluation. Safety outcomes included the rate of ocular adverse events and mesopic contrast sensitivity. Results: Mean binocular and monocular distance-corrected and uncorrected VAs of 0.1 logMAR or better (approximately 20/25 Snellen) were achieved at distance, intermediate, and near. Overall, ≥70% of patients achieved binocular 0.1 logMAR vision or better across all distances. TFNT00 maintained a mean VA of 0.1 logMAR or better at the defocus range of +0.5 diopters (D) to -2.5 D (200 cm to 40 cm). The subjective symptom questionnaireassessed frequency of halo visual disturbances was low at Month 3; halos were reported "none of the time" to "only some of the time" in 86.6% of patients. The large majority of patients (98.5%) were "satisfied" or "very satisfied" with their near, intermediate, and distance vision at Month 3, and ≥94.0% of patients reported spectacle independence for tasks at all distances. The adverse event rate was low; no patients discontinued due to an adverse event. Conclusion: TFNT00 provided a continuous range of vision of 20/25 or better for distance to near and performed effectively at an intermediate functional distance of 60 cm, resulting in high levels of spectacle independence and patient satisfaction. TFNT00 demonstrated a good safety profile and a low post-operative frequency of halo visual disturbances.

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“…Multifocal intraocular lenses (MIOLs), aimed to meet the increasing demand for spectacle independence, has played a very important role in cataract surgery [2]. AT LISA tri 839MP (Carl Zeiss Meditec, Jena, Germany), a diffractive trifocal intraocular lens (IOL) which distributes the light into 3 focal points, has already been proved to be able to provide great visual quality while correcting presbyopia [3][4][5][6]. SBL-3 (Lenstec, Inc., Christ Church, Barbados), a refractive rotationally asymmetric bifocal IOL, has also been widely adopted by surgeons around the world [7][8][9].…”

Section: Introductionmentioning

confidence: 99%

Comparison of visual outcomes of a diffractive trifocal intraocular lens and a refractive bifocal intraocular lens in eyes with axial myopia: a prospective cohort study

Liu¹,

Gao²,

Tang³

et al. 2022

BMC Ophthalmol

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Background To assess and compare the efficacy, safety, accuracy, predictability and visual quality of a diffractive trifocal intraocular lens (IOL) and a refractive rotationally asymmetric bifocal IOL in eyes with axial myopia. Methods This prospective cohort study enrolled patients with implantation of the diffractive trifocal IOL or the refractive bifocal IOL. Eyes were divided into four groups according to the IOL implanted and axial length. Manifest refraction, uncorrected and corrected visual acuity at far, intermediate and near distances, prediction error of spherical equivalent (SE), contrast sensitivity and aberrations were evaluated three months after surgery. Results In total, 80 eyes of 80 patients were included: 20 eyes in each group. Three months postoperatively, the corrected distance visual acuity of two trifocal groups were significantly better than the axial myopia bifocal group (P = 0.007 and 0.043). There was no significant difference of postoperative SE (P = 0.478), but the SE predictability of the trifocal IOL was better, whether in axial myopia groups (P = 0.015) or in control groups (P = 0.027). The contrast sensitivity was similar among four groups. The total aberration, higher order aberration and trefoil aberration of bifocal groups were significantly higher (all P < 0.001). Conclusions The diffractive trifocal IOL and the refractive bifocal IOL both provided good efficacy, accuracy, predictability and safety for eyes with axial myopia. By contrast, the trifocal IOL had a better performance in corrected distance visual acuity and visual quality. Trial registration The study was retrospectively registered and posted on clinicaltrials.gov at 12/02/2020 (NCT04265846).

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Visual outcomes and patient satisfaction after bilateral implantation of a new trifocal diffractive intraocular lens

Cited by 8 publications

References 23 publications

Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens

Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens

Clinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population

Comparison of visual outcomes of a diffractive trifocal intraocular lens and a refractive bifocal intraocular lens in eyes with axial myopia: a prospective cohort study

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