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1.
Clin Ophthalmol ; 18: 1491-1501, 2024.
Article in English | MEDLINE | ID: mdl-38827774

ABSTRACT

Purpose: To evaluate binocular intermediate visual acuity (IVA), depth of focus, and other visual outcomes achieved with a monofocal aspheric intraocular lens (IOL) using pooled data from 2 randomized, double-masked, controlled trials. Patients and Methods: The studies conducted at 32 sites included patients aged ≥22 years with bilateral cataracts, preoperative corneal astigmatism 1.0 D, and lens power 18.0-25.0 D. Patients received bilateral AcrySof IQ IOLs (SN60WF). Primary endpoint data were collected at month 6. Binocular uncorrected and corrected distance visual acuity (UDVA and CDVA) at 4 m, binocular uncorrected and corrected IVA (UIVA and DCIVA) at 66 cm, manifest refraction spherical equivalent (MRSE), and binocular defocus curve at 4 m were assessed under photopic conditions. Validated questionnaires were used to assess spectacle use and quality of vision. Results: Of 233 patients who received SN60WF, 228 had visual acuity data at 6 months. Under photopic conditions, 51% of the eyes had pupils >4 mm, 40% had pupils 3-4 mm, and 9% had pupils <3 mm. Mean ± SD UDVA and CDVA were -0.019 ± 0.110 and -0.088 ± 0.082 logMAR, respectively. Mean ± SD UIVA and DCIVA were 0.125 ± 0.145 and 0.196 ± 0.139 logMAR, respectively. UIVA and DCIVA of 20/32 or better were achieved by 83% (188/228) and 71% (162/228) of patients, respectively. Mean ± SD MRSE was -0.007 ± 0.404 D for the first eye and 0.036 ± 0.371 for the second eye. The defocus curve demonstrated binocular vision of 0.24 logMAR or better from +1.2 to -1.5 D. Spectacle independence for distance and intermediate vision was reported by 86% and 41% of the patients, respectively. Based on questionnaires, 61%, 79%, and 65% of the patients did not experience starbursts, halos, or glare. Conclusion: A monofocal aspheric IOL (SN60WF) assessed in a large, pooled study provided excellent distance vision and clinically functional intermediate vision.

2.
Ophthalmol Ther ; 12(2): 1157-1171, 2023 Apr.
Article in English | MEDLINE | ID: mdl-36745314

ABSTRACT

INTRODUCTION: A systematic literature review and meta-analysis was conducted to identify and obtain a precise single summary estimate on complete spectacle independence after bilateral implantation of a trifocal intraocular lens (IOL) (AcrySof PanOptix, TFNTXX/TFATXX) for patients undergoing cataract surgery. METHODS: A search was conducted in PubMed from January 2017 to September 2021. Relevant congress presentations were also searched to include data from completed studies not yet published. Search terms included the intervention (TFNTXX, TFATXX, PanOptix) and outcomes of interest (patient-reported spectacle independence rates). A Bayesian random-effects meta-analysis was conducted, providing a pooled estimate (median and its 95% credible interval) of complete spectacle independence rates among cataract surgery patients. Subgroup analyses evaluated spectacle independence after cataract surgery across different working distances (near, intermediate, far). RESULTS: Nineteen unique clinical studies were identified. Based on a meta-analysis of 13 studies (N = 513 patients), the complete spectacle independence rate after cataract surgery with TFNTXX/TFATXX IOL was 91.6% (95% credible interval 86.8-95.9%). Additionally, the spectacle independence rates at each focal point (N = 13 studies, 603 patients) were 89.6% (near), 96.3% (intermediate), and 95.9% (far). CONCLUSIONS: This meta-analysis demonstrated that at least nine out of ten patients receiving TFNTXX/TFATXX trifocal IOL during cataract surgery can expect to achieve complete spectacle independence. This study provides informative data for clinicians and patients to feel confident in the use of trifocal intraocular lenses as presbyopia-correcting IOLs that offer high rates of complete spectacle independence.

3.
J Cataract Refract Surg ; 48(11): 1297-1304, 2022 11 01.
Article in English | MEDLINE | ID: mdl-35616507

ABSTRACT

PURPOSE: To evaluate the effectiveness and safety of the DFT015 intraocular lens (IOL) (AcrySof IQ Vivity Extended Vision) compared with an aspheric monofocal control IOL (AcrySof IQ model SN60WF). SETTING: 11 investigation sites in the U.S. DESIGN: Prospective randomized controlled clinical study. METHODS: Patients aged 22 years or older with bilateral cataracts were randomized to receive bilateral implantation of DFT015 or SN60WF. The 4 coprimary effectiveness outcomes (6 months postoperatively) were monocular photopic distance-corrected intermediate visual acuity (DCIVA), monocular photopic corrected distance visual acuity (CDVA), monocular depth of focus (DoF), and the percentage of patients achieving a DCIVA of 0.2 logMAR or better. The mean monocular photopic distance-corrected near visual acuity (DCNVA) was a secondary effectiveness outcome. Safety and patient-reported visual disturbances were evaluated through questionnaires. RESULTS: 218 patients (435 eyes) completed the study. Compared with SN60WF, DFT015 demonstrated superior mean monocular photopic DCIVA ( P &lt; .001), noninferior mean monocular photopic CDVA, and superior mean monocular photopic DCNVA ( P &lt; .001) and provided an extended monocular DoF (increase of 0.54 diopters at 0.2 logMAR). With DFT015, 78 first eyes (72.9%) achieved a DCIVA of 0.2 logMAR or better at 6 months. Incidences of ocular serious adverse events and patient-reported most bothersome visual disturbances were low and consistent between groups. CONCLUSIONS: DFT015 is safe and effective for the visual correction of aphakia, exceeding American National Standards Institute criteria for an extended depth-of-focus IOL by providing superior DCIVA and DCNVA, with comparable CDVA and visual disturbances to the SN60WF monofocal IOL.


Subject(s)
Lenses, Intraocular , Phacoemulsification , Humans , Lens Implantation, Intraocular , Prospective Studies , Prosthesis Design , Pseudophakia , Refraction, Ocular
4.
J Cataract Refract Surg ; 48(8): 961-968, 2022 08 01.
Article in English | MEDLINE | ID: mdl-35137697

ABSTRACT

Defocus curve assessment is used to emulate defocus over a range of distances and is a valuable tool that is used to differentiate the performance of presbyopia-correcting intraocular lenses. However, defocus curves are limited by a lack of standardization, and multiple factors can affect their generation and interpretation. This review discusses key factors that influence the assessment of defocus curves, including pupil size, level of contrast, sphere vs cylinder defocus, viewing distance, monocular vs binocular assessment, use of Snellen vs logMAR charts, and diopter range and step size. Moreover, different methods to analyze defocus curves, including the direct comparison method, range-of-focus analysis, and area under the curve analysis, can affect result interpretation. A good understanding of these factors and standardization of the methodology are important to ensure optimal cross-study comparisons.


Subject(s)
Lenses, Intraocular , Presbyopia , Humans , Prosthesis Design , Refraction, Ocular , Vision, Binocular , Visual Acuity
5.
J Cataract Refract Surg ; 48(2): 136-143, 2022 Feb 01.
Article in English | MEDLINE | ID: mdl-34288635

ABSTRACT

PURPOSE: To evaluate the effectiveness and safety of a new presbyopia-correcting intraocular lens (IOL) with a nondiffractive design, DFT015, compared with an aspheric monofocal IOL, SN60WF. SETTING: 19 investigational sites in 4 countries: Australia, Canada, Spain, and the United Kingdom. DESIGN: Prospective, randomized, parallel-group, controlled, assessor- and patient-masked clinical study. METHODS: Participants aged ≥22 years with bilateral cataracts were randomized to DFT015 or SN60WF in a 5:4 ratio and masked until final postoperative follow-up at month 6. The primary effectiveness objective was superiority of DFT015 over SN60WF in mean monocular photopic distance-corrected intermediate visual acuity (DCIVA) at month 3. Secondary effectiveness objectives included noninferiority of DFT015 to SN60WF in mean monocular photopic corrected distance visual acuity (CDVA) and superiority in the mean monocular photopic distance-corrected near visual acuity (DCNVA) at month 3. Visual disturbances were assessed at month 6. RESULTS: 282 patients were randomized to DFT015 (n = 159) or SN60WF (n = 123). All effectiveness objectives were achieved at month 3 in first eyes. For monocular photopic results in first eyes, DFT015 demonstrated superior mean DCIVA (least squares means of -0.139 logMAR in favor of DFT015, P < .001), noninferior mean CDVA (97.5% upper confidence limit [UCL] of the difference was <0.1 logMAR) and superior mean DCNVA (95% UCL of the difference was <0.0 logMAR) compared with SN60WF at month 6. DFT015 exhibited a similar visual disturbance profile to that of SN60WF. CONCLUSIONS: DFT015 provided superior intermediate and near vision and a similar visual disturbance profile compared with an aspheric monofocal IOL.


Subject(s)
Lenses, Intraocular , Phacoemulsification , Presbyopia , Humans , Lens Implantation, Intraocular , Presbyopia/surgery , Prospective Studies , Prosthesis Design
6.
Clin Ophthalmol ; 14: 3439-3450, 2020.
Article in English | MEDLINE | ID: mdl-33116396

ABSTRACT

PURPOSE: The objective of this systematic literature review (SLR) was to collate, report, and critique published evidence related to epidemiology and patient and economic burden of presbyopia. PATIENTS AND METHODS: A systematic literature search was conducted in MEDLINE®, Embase®, and Cochrane Library databases from the time of inception through October 2018 using Cochrane methodology. Studies published in English language reporting on epidemiology and patient and economic burden of presbyopia were included. RESULTS: Initial systematic literature search yielded 2,228 citations, of which 55 met the inclusion criteria (epidemiology, 44; patient burden, 14; economic burden, 1) and were included in this review. Globally, 1.09 billion people are estimated to be affected by presbyopia. The reported presbyopia prevalence varied across regions and by age groups, with the highest prevalence of 90% reported in the Latin America region in adults ≥35 years. Presbyopic patients report up to 22% decrease in quality-of-life (QoL) score, and up to 80% patients with uncorrected presbyopia report difficulty in performing near-vision related tasks. About 12% of presbyopes required help in performing routine activities, and these visual limitations reportedly induce distress and low self-esteem in presbyopia patients. Uncorrected presbyopia led to a 2-fold increased difficulty in near-vision-related tasks and a >8-fold increased difficulty in very demanding near-vision-related tasks. Further, uncorrected presbyopia leads to a decrement in patients' QoL, evident by the low utility values reported in the literature. Annual global productivity losses due to uncorrected and under-corrected presbyopia in working-age population (<50 years) were estimated at US$ 11 billion (0.016% of the global domestic product (GDP) in 2011, which increased to US$ 25.4 billion if all people aged <65 years were assumed to be productive. CONCLUSION: Uncorrected presbyopia affects patients' vision-related quality of life due to difficulty in performing near-vision-related tasks. In addition, un-/under-corrected presbyopia could lead to productivity losses in working-age adults.

7.
Optom Vis Sci ; 97(8): 565-572, 2020 08.
Article in English | MEDLINE | ID: mdl-32769842

ABSTRACT

SIGNIFICANCE: Lotrafilcon B lenses packaged in and cared for with block copolymer-containing (polyoxyethylene-polyoxybutylene; EOBO) lens care solutions resulted in lower cholesterol extraction than each of the habitual silicone hydrogel lens/multipurpose solution (MPS) regimens tested. PURPOSE: This study aimed to compare the extracted cholesterol of lotrafilcon B lenses packaged in and cared for with EOBO-containing lens care solutions with the extracted cholesterol of habitual silicone hydrogel lenses cared for with MPS not containing EOBO. METHODS: In this prospective, randomized, observer-masked parallel study, habitual wearers of senofilcon C, senofilcon A, comfilcon A, and samfilcon A contact lenses using a non-EOBO MPS were randomized 1:1 to lotrafilcon B lenses packaged in and cared for with EOBO-containing solutions or to their habitual lenses and MPS. Subjects randomized to lotrafilcon B were further randomized to one of two EOBO-containing lens care solutions, OPTI-FREE PUREMOIST or CLEAR CARE PLUS with HydraGlyde (Alcon Laboratories, Inc., Fort Worth, TX). A subset of right eye lenses was collected after wear, and total cholesterol was extracted and measured using a fluorometric enzymatic assay. RESULTS: Of 143 lenses analyzed, 95 were from subjects randomized to their habitual lenses/MPS and 48 to lotrafilcon B + EOBO lenses plus CLEAR CARE PLUS with HydraGlyde or OPTI-FREE PUREMOIST. The mean amounts of cholesterol extracted from lotrafilcon B + EOBO lenses cared for with CLEAR CARE PLUS with HydraGlyde (0.28 ± 0.18 µg/lens) and OPTI-FREE PUREMOIST (0.28 ± 0.48 µg/lens) were significantly lower than those extracted from senofilcon C (4.18 ± 3.25 µg/lens), senofilcon A (2.19 ± 2.69 µg/lens), comfilcon A (2.17 ± 1.47 µg/lens), and samfilcon A (2.07 ± 1.48 µg/lens) lenses used with MPS (P < .0001 each). CONCLUSIONS: Cholesterol sorption was significantly lower in wearers of lotrafilcon B lenses cared for with polyoxyethylene-polyoxybutylene-containing lens care solutions than in users of habitual silicone hydrogel lenses cared for with non-polyoxyethylene-polyoxybutylene MPS.


Subject(s)
Cholesterol/analysis , Contact Lens Solutions/chemistry , Contact Lenses, Hydrophilic , Hydrogels/chemistry , Silicone Elastomers/chemistry , Silicones/chemistry , Tears/chemistry , Adult , Alkenes , Double-Blind Method , Female , Fluorometry , Humans , Male , Polyethylene Glycols , Product Packaging , Prospective Studies
8.
J Public Health Manag Pract ; 17(4): 381-7, 2011.
Article in English | MEDLINE | ID: mdl-21617418

ABSTRACT

Public health social work is committed to improving the health and well-being of individuals and communities. Collaborative partnerships can be a tremendous resource and valuable approach to meeting community needs. This article discusses the essential role of partnership and community learning through the case study of a student-faculty team engaged in collaborative research on homelessness in upstate New York in an effort to inform the development of a community affordable housing plan. The goals of the project were to (1) improve understanding of homelessness at the local level, (2) contribute to community planning efforts to end homelessness, and (3) enrich public health social work skills. This case study describes the various ways in which collaboration is cultivated and infused throughout the life of a project. The authors reflect on benefits and challenges of collaboration, and suggest considerations for designing collaborative research projects. This article discusses the impact faculty-student and college-community collaborative partnerships can have on expanding knowledge and enhancing community well-being.


Subject(s)
Community-Based Participatory Research , Community-Institutional Relations , Problem-Based Learning , Public Health/economics , Social Work/education , Ill-Housed Persons , Humans , New York , Power, Psychological , Universities
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