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Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial
To report the efficacy and safety of large diameter scleral lenses and determine their suitability in Asian subjects with intractable ocular surface diseases. This prospective study enrolled intractable ocular surface diseases subjects with uncorrected visual acuity > counting finger but ≥ 0.3 lo...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7840975/ https://www.ncbi.nlm.nih.gov/pubmed/33504920 http://dx.doi.org/10.1038/s41598-021-82010-z |
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author | Moon, Jayoon Lee, Sang-Mok Hyon, Joon Young Kim, Mee Kum Oh, Joo Youn Choi, Hyuk Jin |
author_facet | Moon, Jayoon Lee, Sang-Mok Hyon, Joon Young Kim, Mee Kum Oh, Joo Youn Choi, Hyuk Jin |
author_sort | Moon, Jayoon |
collection | PubMed |
description | To report the efficacy and safety of large diameter scleral lenses and determine their suitability in Asian subjects with intractable ocular surface diseases. This prospective study enrolled intractable ocular surface diseases subjects with uncorrected visual acuity > counting finger but ≥ 0.3 logMAR and best-corrected visual acuity (BCVA) ≥ 0.3 logMAR, to fit large diameter scleral lenses for 12 weeks. 21 eyes (13 subjects) consisting ten eyes (47.6%) with persistent epithelial defects, 6 (28.6%) with graft-versus-host disease, 4 (19.0%) with Stevens–Johnson syndrome and one (4.8%) with severe dry eye were ultimately enrolled. Primary outcome measures were the visual acuity, corneal and conjunctival fluorescein staining, Ocular Surface Disease Index (OSDI), and National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25). At week 12 with large diameter scleral lenses, BCVA improved from 0.77 logMAR to 0.27 logMAR (P < 0.001). High-grade corneal and conjunctival fluorescein staining proportion decreased from 61.90 to 14.29% and 52.38 to 9.52%, respectively (P = 0.0036 and 0.0063, respectively). OSDI and NEI-VFQ-25 improved from 67.89 to 34.69 and 51.40 to 64.48, respectively (P < 0.001). No adverse effects were observed. In Asians with intractable ocular surface diseases, large diameter scleral lens improves visual acuity and alleviates signs and symptoms of ocular surface diseases without any significant complications. Trial registration Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea (Project No. HI12C0015 (A120018)). Clinical Trials.gov, NCT04535388. Registered 18 August 2020—Retrospectively registered, http://clinicaltrials.gov/ct2/show/NCT04535388. |
format | Online Article Text |
id | pubmed-7840975 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-78409752021-01-28 Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial Moon, Jayoon Lee, Sang-Mok Hyon, Joon Young Kim, Mee Kum Oh, Joo Youn Choi, Hyuk Jin Sci Rep Article To report the efficacy and safety of large diameter scleral lenses and determine their suitability in Asian subjects with intractable ocular surface diseases. This prospective study enrolled intractable ocular surface diseases subjects with uncorrected visual acuity > counting finger but ≥ 0.3 logMAR and best-corrected visual acuity (BCVA) ≥ 0.3 logMAR, to fit large diameter scleral lenses for 12 weeks. 21 eyes (13 subjects) consisting ten eyes (47.6%) with persistent epithelial defects, 6 (28.6%) with graft-versus-host disease, 4 (19.0%) with Stevens–Johnson syndrome and one (4.8%) with severe dry eye were ultimately enrolled. Primary outcome measures were the visual acuity, corneal and conjunctival fluorescein staining, Ocular Surface Disease Index (OSDI), and National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25). At week 12 with large diameter scleral lenses, BCVA improved from 0.77 logMAR to 0.27 logMAR (P < 0.001). High-grade corneal and conjunctival fluorescein staining proportion decreased from 61.90 to 14.29% and 52.38 to 9.52%, respectively (P = 0.0036 and 0.0063, respectively). OSDI and NEI-VFQ-25 improved from 67.89 to 34.69 and 51.40 to 64.48, respectively (P < 0.001). No adverse effects were observed. In Asians with intractable ocular surface diseases, large diameter scleral lens improves visual acuity and alleviates signs and symptoms of ocular surface diseases without any significant complications. Trial registration Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea (Project No. HI12C0015 (A120018)). Clinical Trials.gov, NCT04535388. Registered 18 August 2020—Retrospectively registered, http://clinicaltrials.gov/ct2/show/NCT04535388. Nature Publishing Group UK 2021-01-27 /pmc/articles/PMC7840975/ /pubmed/33504920 http://dx.doi.org/10.1038/s41598-021-82010-z Text en © The Author(s) 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Article Moon, Jayoon Lee, Sang-Mok Hyon, Joon Young Kim, Mee Kum Oh, Joo Youn Choi, Hyuk Jin Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial |
title | Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial |
title_full | Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial |
title_fullStr | Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial |
title_full_unstemmed | Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial |
title_short | Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial |
title_sort | large diameter scleral lens benefits for asians with intractable ocular surface diseases: a prospective, single-arm clinical trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7840975/ https://www.ncbi.nlm.nih.gov/pubmed/33504920 http://dx.doi.org/10.1038/s41598-021-82010-z |
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