Dataset Information

Evaluation of Visual and Subjective Outcomes with Mix-and-Match of Three One-Piece Tecnis Multifocal IOLs of Varying Add Powers.

ABSTRACT: Purpose:To evaluate visual and subjective outcomes after bilateral mix-and-match implantation of one-piece diffractive multifocal IOLs in different near add powers (+2.75 D, +3.25 D, +4.0 D). Setting:Four US clinics. Design:Prospective, multi-center, parallel comparison clinical study design. Patients and Methods:Two treatment groups received implantation with either the +3.25 D (ZLB00) or the +4.00 D (ZMB00) Tecnis® Multifocal 1-piece IOL in their non-dominant eye, and the +2.75 D (ZKB00) Tecnis Multifocal 1-piece IOL in their dominant eye (Abbott Medical Optics, Inc., Santa Ana, CA). Each study patient underwent the same routine cataract extraction procedures for each eye, with the second eye scheduled to undergo cataract extraction within 7 to 30 days after the 1st eye surgery. Visual and subjective outcomes were evaluated at 90 days after 2nd eye surgery for the two groups: +3.25D/+2.75D (n=41) and +4.00D/+2.75D (n=36). Results:Mean binocular uncorrected distance visual acuities at 90 days postop were 0.02 ± 0.082 (+3.25D/+2.75D) vs 0.07 ± 0.128 (+4.00D/+2.75D) (p=0.025). Mean binocular uncorrected intermediate visual acuities at 90 days postop were 0.14 ± 0.185 (+3.25D/+2.75D) vs 0.26 ± 0.261 (+4.00D/+2.75D) (p=0.024). Mean binocular uncorrected near visual acuities at 90 days postop were 0.06 ± 0.098 (+3.25D/+2.75D) vs 0.19 ± 0.286 (+4.00D/+2.75D) (p=0.018). Over 88% of patients reported "none" for visual symptoms of glare, halos, starburst, or other. Freedom from glasses or contacts was reported by groups +3.25D/+2.75D and +4.00D/+2.75D as follows: distance (95.1% vs 97.1%), intermediate (92.7% vs 94.1%), and near activities (82.9% vs 64.7%). Conclusion:At 90 days postoperatively, both groups demonstrated good visual and subjective outcomes; however, differences in near and intermediate outcomes favored the +3.25/+2.75 IOL combination. Clinicaltrialsgov Registration:NCT02863159 (08/11/2016).

SUBMITTER: Dell SJ

PROVIDER: S-EPMC7532892 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Evaluation of Visual and Subjective Outcomes with Mix-and-Match of Three One-Piece Tecnis Multifocal IOLs of Varying Add Powers.

Dell Steven J SJ

Clinical ophthalmology (Auckland, N.Z.) 20200929

<h4>Purpose</h4>To evaluate visual and subjective outcomes after bilateral mix-and-match implantation of one-piece diffractive multifocal IOLs in different near add powers (+2.75 D, +3.25 D, +4.0 D).<h4>Setting</h4>Four US clinics.<h4>Design</h4>Prospective, multi-center, parallel comparison clinical study design.<h4>Patients and methods</h4>Two treatment groups received implantation with either the +3.25 D (ZLB00) or the +4.00 D (ZMB00) Tecnis<sup>®</sup> Multifocal 1-piece IOL in their non-dom ...[more]

PMID: 33061276

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Project description:BackgroundTo compare the visual performance of MF30 asymmetric refractive multifocal intraocular lenses (MIOLs) with ZMB00 all optic zone diffractive MIOLs.MethodsThis is a prospective study. Patients that underwent phacoemulsification were divided into two groups according to the type of MIOLs used: 35 patients were implanted with asymmetric refractive MIOLs and 35 patients with all optic zone diffractive MIOLs. Visual acuity (VA), refraction, defocus curves, objective optical quality, and a questionnaire evaluating quality of life were measured at 3 months postoperatively.ResultsThere were no significant differences between the two groups in uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), best-corrected distance visual acuity (BCDVA), or distance-corrected near visual acuity (DCNVA). However, the uncorrected intermediate VA was 0.24±0.10 in the refractive group and 0.31±0.13 in the diffractive group (P<0.05), and the distance-corrected intermediate VA was 0.22±0.09 in the refractive group and 0.31±0.14 in the diffractive group (P<0.05). Defocus curves showed two peaks of maximum vision in both groups. However, the curve between the two peaks in the refractive group was smoother than that of the diffractive group. The modulated transfer function cut-off frequency was 22.74±12.29 c/d in the refractive group and 30.50±10.04 c/d in the diffractive group (P<0.05). The Optical Quality Analysis System (OQAS) values 100% (OV100%) was 0.75±0.41 in the refractive group and 1.02±0.34 in the diffractive group (P<0.05), while the OV20% was 0.52±0.34 in the refractive group and 0.71±0.25 in the diffractive group (P<0.05). There was no significant difference between the two groups in overall satisfaction, spectacle independence ratio, or visual interference phenomenon.ConclusionsBoth MIOLs achieve good VA at distance and near vision. Oculentis MF30 showed better intermediate VA, and Tecnis ZMB00 appears to have better objective visual quality.Trial registrationNCT02234635 (http://www.clinicaltrials.gov).

Project description:The severity of the COVID-19 pandemic and the development of multiple SARS-CoV-2 vaccines expedited vaccine 'mix and match' trials in humans and demonstrated the benefits of mixing vaccines that vary in formulation, strength, and immunogenicity. Heterologous sequential vaccination may be an effective approach for protecting against dengue, as this strategy would mimic the natural route to broad dengue protection and may overcome the imbalances in efficacy of the individual leading live attenuated dengue vaccines. Here we review 'mix and match' vaccination trials against SARS-CoV-2, HIV, and dengue virus and discuss the possible advantages and concerns of future heterologous immunization with the leading dengue vaccines. COVID-19 trials suggest that priming with a vaccine that induces strong cellular responses, such as an adenoviral vectored product, followed by heterologous boost may optimize T cell immunity. Moreover, heterologous vaccination may induce superior humoral immunity compared to homologous vaccination when the priming vaccine induces a narrower response than the boost. The HIV trials reported that heterologous vaccination was associated with broadened antigen responses and that the sequence of the vaccines significantly impacts the regimen's immunogenicity and efficacy. In heterologous dengue immunization trials, where at least one dose was with a live attenuated vaccine, all reported equivalent or increased immunogenicity compared to homologous boost, although one study reported increased reactogenicity. The three leading dengue vaccines have been evaluated for safety and efficacy in thousands of study participants but not in combination in heterologous dengue vaccine trials. Various heterologous regimens including different combinations and sequences should be trialed to optimize cellular and humoral immunity and the breadth of the response while limiting reactogenicity. A blossoming field dedicated to more accurate correlates of protection and enhancement will help confirm the safety and efficacy of these strategies.

Dataset Information

Evaluation of Visual and Subjective Outcomes with Mix-and-Match of Three One-Piece Tecnis Multifocal IOLs of Varying Add Powers.

Publications

Evaluation of Visual and Subjective Outcomes with Mix-and-Match of Three One-Piece Tecnis Multifocal IOLs of Varying Add Powers.

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