Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial

Abstract 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...

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Autores principales:	Jayoon Moon, Sang-Mok Lee, Joon Young Hyon, Mee Kum Kim, Joo Youn Oh, Hyuk Jin Choi
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/8f949a63fd2646d6ab8c281cc8996ccd
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spelling	oai:doaj.org-article:8f949a63fd2646d6ab8c281cc8996ccd2021-12-02T10:48:03ZLarge diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial10.1038/s41598-021-82010-z2045-2322https://doaj.org/article/8f949a63fd2646d6ab8c281cc8996ccd2021-01-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-82010-zhttps://doaj.org/toc/2045-2322Abstract 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 .Jayoon MoonSang-Mok LeeJoon Young HyonMee Kum KimJoo Youn OhHyuk Jin ChoiNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Jayoon Moon Sang-Mok Lee Joon Young Hyon Mee Kum Kim Joo Youn Oh Hyuk Jin Choi Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial
description	Abstract 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	article
author	Jayoon Moon Sang-Mok Lee Joon Young Hyon Mee Kum Kim Joo Youn Oh Hyuk Jin Choi
author_facet	Jayoon Moon Sang-Mok Lee Joon Young Hyon Mee Kum Kim Joo Youn Oh Hyuk Jin Choi
author_sort	Jayoon Moon
title	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_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_sort	large diameter scleral lens benefits for asians with intractable ocular surface diseases: a prospective, single-arm clinical trial
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/8f949a63fd2646d6ab8c281cc8996ccd
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Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial

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