Nitasha R Phatak, William Reindel, Marjorie J Rah, Howard Proskin, Kerry Giedd, Andrew D Pucker
{"title":"3区渐进式设计Kalifilcon a硅水凝胶多焦隐形眼镜的视力性能不受瞳孔大小的影响：一项多中心临床研究的结果。","authors":"Nitasha R Phatak, William Reindel, Marjorie J Rah, Howard Proskin, Kerry Giedd, Andrew D Pucker","doi":"10.2147/OPTO.S513407","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Factors including age, refractive error, and luminance can affect pupil size and may influence the performance of multifocal contact lenses (MFCLs). This post-hoc analysis aimed to investigate correlations between pupil size and vision performance of a 3-Zone Progressive™ design, daily disposable silicone hydrogel (kalifilcon A) MFCL.</p><p><strong>Methods: </strong>Habitual MFCL wearers aged ≥40 years were enrolled in a 3-week, single-arm, bilateral, open-label study to assess near, intermediate, and distant vision performance. Pupil sizes were recorded at dispensing, along with binocular high-contrast visual acuity (VA) by logMAR. VA was assessed at 1- and 3-weeks' follow-up for distance, intermediate, and near vision, and participants rated vision performance using a 0-100 scale (100=most favorable) at both these follow-ups. Responses with score ≥50 were considered favorable. Pearson correlation coefficient (r) was used to determine the correlation significance.</p><p><strong>Results: </strong>Pupil size ranged from 2.0 mm to 7.0 mm. Mean logMAR VA was -0.009, 0.046, and 0.114 (1 week), and -0.012, 0.046, and 0.115 (3 weeks) for distance, intermediate, and near vision, respectively. Statistical analysis of the VA distribution found no significant correlation between VA and pupil size after 1 week of MFCL wear for distance or near vision (r<sup>2</sup>=0.003 and 0.006, respectively; both p≥0.05), and a weak but statistically significant correlation between intermediate VA and pupil size (r<sup>2</sup>=0.017; p<0.05). No correlations were observed after 3 weeks for any distance (all p≥0.05). Participants rated subjective vision highly (84.0±19.9, 89.2±11.8, and 82.5±18.5, respectively at 1 week, and 84.6±18.0, 89.3±12.6, and 84.2±17.9, respectively at 3 weeks). Responses were favorable at both visits (p<0.05). Correlations between vision rating and pupil size were not significant at either visit (p≥0.05).</p><p><strong>Conclusion: </strong>The kalifilcon A daily disposable silicone hydrogel MFCL delivers stable VA and significantly favorable (p<0.05) ratings at all distances for patients with a wide range of pupil sizes.</p>","PeriodicalId":43701,"journal":{"name":"Clinical Optometry","volume":"17 ","pages":"207-215"},"PeriodicalIF":1.8000,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12306539/pdf/","citationCount":"0","resultStr":"{\"title\":\"Vision Performance of a 3-Zone Progressive™ Design Kalifilcon A Silicone Hydrogel Multifocal Contact Lens is Not Influenced by Pupil Size: Findings from a Multicenter Clinical Study.\",\"authors\":\"Nitasha R Phatak, William Reindel, Marjorie J Rah, Howard Proskin, Kerry Giedd, Andrew D Pucker\",\"doi\":\"10.2147/OPTO.S513407\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Factors including age, refractive error, and luminance can affect pupil size and may influence the performance of multifocal contact lenses (MFCLs). This post-hoc analysis aimed to investigate correlations between pupil size and vision performance of a 3-Zone Progressive™ design, daily disposable silicone hydrogel (kalifilcon A) MFCL.</p><p><strong>Methods: </strong>Habitual MFCL wearers aged ≥40 years were enrolled in a 3-week, single-arm, bilateral, open-label study to assess near, intermediate, and distant vision performance. Pupil sizes were recorded at dispensing, along with binocular high-contrast visual acuity (VA) by logMAR. VA was assessed at 1- and 3-weeks' follow-up for distance, intermediate, and near vision, and participants rated vision performance using a 0-100 scale (100=most favorable) at both these follow-ups. Responses with score ≥50 were considered favorable. Pearson correlation coefficient (r) was used to determine the correlation significance.</p><p><strong>Results: </strong>Pupil size ranged from 2.0 mm to 7.0 mm. Mean logMAR VA was -0.009, 0.046, and 0.114 (1 week), and -0.012, 0.046, and 0.115 (3 weeks) for distance, intermediate, and near vision, respectively. Statistical analysis of the VA distribution found no significant correlation between VA and pupil size after 1 week of MFCL wear for distance or near vision (r<sup>2</sup>=0.003 and 0.006, respectively; both p≥0.05), and a weak but statistically significant correlation between intermediate VA and pupil size (r<sup>2</sup>=0.017; p<0.05). No correlations were observed after 3 weeks for any distance (all p≥0.05). Participants rated subjective vision highly (84.0±19.9, 89.2±11.8, and 82.5±18.5, respectively at 1 week, and 84.6±18.0, 89.3±12.6, and 84.2±17.9, respectively at 3 weeks). Responses were favorable at both visits (p<0.05). Correlations between vision rating and pupil size were not significant at either visit (p≥0.05).</p><p><strong>Conclusion: </strong>The kalifilcon A daily disposable silicone hydrogel MFCL delivers stable VA and significantly favorable (p<0.05) ratings at all distances for patients with a wide range of pupil sizes.</p>\",\"PeriodicalId\":43701,\"journal\":{\"name\":\"Clinical Optometry\",\"volume\":\"17 \",\"pages\":\"207-215\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2025-07-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12306539/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Optometry\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2147/OPTO.S513407\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Optometry","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/OPTO.S513407","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
Vision Performance of a 3-Zone Progressive™ Design Kalifilcon A Silicone Hydrogel Multifocal Contact Lens is Not Influenced by Pupil Size: Findings from a Multicenter Clinical Study.
Purpose: Factors including age, refractive error, and luminance can affect pupil size and may influence the performance of multifocal contact lenses (MFCLs). This post-hoc analysis aimed to investigate correlations between pupil size and vision performance of a 3-Zone Progressive™ design, daily disposable silicone hydrogel (kalifilcon A) MFCL.
Methods: Habitual MFCL wearers aged ≥40 years were enrolled in a 3-week, single-arm, bilateral, open-label study to assess near, intermediate, and distant vision performance. Pupil sizes were recorded at dispensing, along with binocular high-contrast visual acuity (VA) by logMAR. VA was assessed at 1- and 3-weeks' follow-up for distance, intermediate, and near vision, and participants rated vision performance using a 0-100 scale (100=most favorable) at both these follow-ups. Responses with score ≥50 were considered favorable. Pearson correlation coefficient (r) was used to determine the correlation significance.
Results: Pupil size ranged from 2.0 mm to 7.0 mm. Mean logMAR VA was -0.009, 0.046, and 0.114 (1 week), and -0.012, 0.046, and 0.115 (3 weeks) for distance, intermediate, and near vision, respectively. Statistical analysis of the VA distribution found no significant correlation between VA and pupil size after 1 week of MFCL wear for distance or near vision (r2=0.003 and 0.006, respectively; both p≥0.05), and a weak but statistically significant correlation between intermediate VA and pupil size (r2=0.017; p<0.05). No correlations were observed after 3 weeks for any distance (all p≥0.05). Participants rated subjective vision highly (84.0±19.9, 89.2±11.8, and 82.5±18.5, respectively at 1 week, and 84.6±18.0, 89.3±12.6, and 84.2±17.9, respectively at 3 weeks). Responses were favorable at both visits (p<0.05). Correlations between vision rating and pupil size were not significant at either visit (p≥0.05).
Conclusion: The kalifilcon A daily disposable silicone hydrogel MFCL delivers stable VA and significantly favorable (p<0.05) ratings at all distances for patients with a wide range of pupil sizes.
期刊介绍：
Clinical Optometry is an international, peer-reviewed, open access journal focusing on clinical optometry. All aspects of patient care are addressed within the journal as well as the practice of optometry including economic and business analyses. Basic and clinical research papers are published that cover all aspects of optics, refraction and its application to the theory and practice of optometry. Specific topics covered in the journal include: Theoretical and applied optics, Delivery of patient care in optometry practice, Refraction and correction of errors, Screening and preventative aspects of eye disease, Extended clinical roles for optometrists including shared care and provision of medications, Teaching and training optometrists, International aspects of optometry, Business practice, Patient adherence, quality of life, satisfaction, Health economic evaluations.
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