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The Efficacy and Safety of New-Generation Intense Pulsed Light in the Treatment of Meibomian Gland Dysfunction-Related Dry Eye: A Multicenter, Randomized, Patients-Blind, Parallel-Control, Non-Inferiority Clinical Trial
INTRODUCTION: This study aimed to evaluate the efficacy and safety of a new-generation intense pulsed light (IPL) device in improving the symptoms and signs of meibomian gland dysfunction (MGD)-related dry eye, and compare it with a traditional IPL device. METHODS: This multicenter randomized contro...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9437192/ https://www.ncbi.nlm.nih.gov/pubmed/35974296 http://dx.doi.org/10.1007/s40123-022-00556-1 |
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author | Jiang, Xiaodan Yuan, Hao Zhang, Mingzhou Lv, Huibin Chou, Yilin Yang, Jiarui Li, Xuemin |
author_facet | Jiang, Xiaodan Yuan, Hao Zhang, Mingzhou Lv, Huibin Chou, Yilin Yang, Jiarui Li, Xuemin |
author_sort | Jiang, Xiaodan |
collection | PubMed |
description | INTRODUCTION: This study aimed to evaluate the efficacy and safety of a new-generation intense pulsed light (IPL) device in improving the symptoms and signs of meibomian gland dysfunction (MGD)-related dry eye, and compare it with a traditional IPL device. METHODS: This multicenter randomized controlled trial enrolled 132 patients with MGD-related dry eye from two centers. Patients were randomly assigned into the new-generation IPL (Eyesis) group or traditional IPL (E-Eye) group, and then blinded to receive treatment on days 0 and 7. Ocular Surface Disease Index (OSDI), tear meniscus height (TMH), tear breakup time (TBUT), corneal fluorescein staining (CFS), Schirmer test, and meibomian gland signs were evaluated on days 0, 7, and 14. The primary outcome was defined as the effective rate of treating MGD at day 14. Any adverse events were recorded for safety assessment. Intergroup comparisons and non-inferiority analysis were performed. p values less than 0.05 were considered statistically significant. RESULTS: Basic information showed no significant difference between treatment groups. The intergroup difference of the effective rate was − 1.7% in the left eye and 1.6% in right eye, verifying the non-inferiority of the Eyesis device (p = 0.927). Significant improvements in OSDI, TBUT, Schirmer test, TMH, CFS, and meibomian gland signs were observed in Eyesis group on days 7 and 14 (all p < 0.05). Compared to the E-Eye group, the Eyesis group achieved more significant improvements in OSDI, TBUT, Schirmer test, TMH, and meibum quality (all p < 0.05). There was no significant difference in the incidences of adverse events between groups (p = 1.000). CONCLUSIONS: The new-generation IPL was effective and safe in relieving the symptoms and signs of MGD-related dry eye, exhibiting a non-inferior effective rate compared to the traditional IPL. Additionally, Eyesis showed more clinical benefits over E-Eye in alleviating symptoms, increasing tear film stability and improving meibomian gland function. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40123-022-00556-1. |
format | Online Article Text |
id | pubmed-9437192 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-94371922022-09-03 The Efficacy and Safety of New-Generation Intense Pulsed Light in the Treatment of Meibomian Gland Dysfunction-Related Dry Eye: A Multicenter, Randomized, Patients-Blind, Parallel-Control, Non-Inferiority Clinical Trial Jiang, Xiaodan Yuan, Hao Zhang, Mingzhou Lv, Huibin Chou, Yilin Yang, Jiarui Li, Xuemin Ophthalmol Ther Original Research INTRODUCTION: This study aimed to evaluate the efficacy and safety of a new-generation intense pulsed light (IPL) device in improving the symptoms and signs of meibomian gland dysfunction (MGD)-related dry eye, and compare it with a traditional IPL device. METHODS: This multicenter randomized controlled trial enrolled 132 patients with MGD-related dry eye from two centers. Patients were randomly assigned into the new-generation IPL (Eyesis) group or traditional IPL (E-Eye) group, and then blinded to receive treatment on days 0 and 7. Ocular Surface Disease Index (OSDI), tear meniscus height (TMH), tear breakup time (TBUT), corneal fluorescein staining (CFS), Schirmer test, and meibomian gland signs were evaluated on days 0, 7, and 14. The primary outcome was defined as the effective rate of treating MGD at day 14. Any adverse events were recorded for safety assessment. Intergroup comparisons and non-inferiority analysis were performed. p values less than 0.05 were considered statistically significant. RESULTS: Basic information showed no significant difference between treatment groups. The intergroup difference of the effective rate was − 1.7% in the left eye and 1.6% in right eye, verifying the non-inferiority of the Eyesis device (p = 0.927). Significant improvements in OSDI, TBUT, Schirmer test, TMH, CFS, and meibomian gland signs were observed in Eyesis group on days 7 and 14 (all p < 0.05). Compared to the E-Eye group, the Eyesis group achieved more significant improvements in OSDI, TBUT, Schirmer test, TMH, and meibum quality (all p < 0.05). There was no significant difference in the incidences of adverse events between groups (p = 1.000). CONCLUSIONS: The new-generation IPL was effective and safe in relieving the symptoms and signs of MGD-related dry eye, exhibiting a non-inferior effective rate compared to the traditional IPL. Additionally, Eyesis showed more clinical benefits over E-Eye in alleviating symptoms, increasing tear film stability and improving meibomian gland function. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40123-022-00556-1. Springer Healthcare 2022-08-16 2022-10 /pmc/articles/PMC9437192/ /pubmed/35974296 http://dx.doi.org/10.1007/s40123-022-00556-1 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial 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-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Jiang, Xiaodan Yuan, Hao Zhang, Mingzhou Lv, Huibin Chou, Yilin Yang, Jiarui Li, Xuemin The Efficacy and Safety of New-Generation Intense Pulsed Light in the Treatment of Meibomian Gland Dysfunction-Related Dry Eye: A Multicenter, Randomized, Patients-Blind, Parallel-Control, Non-Inferiority Clinical Trial |
title | The Efficacy and Safety of New-Generation Intense Pulsed Light in the Treatment of Meibomian Gland Dysfunction-Related Dry Eye: A Multicenter, Randomized, Patients-Blind, Parallel-Control, Non-Inferiority Clinical Trial |
title_full | The Efficacy and Safety of New-Generation Intense Pulsed Light in the Treatment of Meibomian Gland Dysfunction-Related Dry Eye: A Multicenter, Randomized, Patients-Blind, Parallel-Control, Non-Inferiority Clinical Trial |
title_fullStr | The Efficacy and Safety of New-Generation Intense Pulsed Light in the Treatment of Meibomian Gland Dysfunction-Related Dry Eye: A Multicenter, Randomized, Patients-Blind, Parallel-Control, Non-Inferiority Clinical Trial |
title_full_unstemmed | The Efficacy and Safety of New-Generation Intense Pulsed Light in the Treatment of Meibomian Gland Dysfunction-Related Dry Eye: A Multicenter, Randomized, Patients-Blind, Parallel-Control, Non-Inferiority Clinical Trial |
title_short | The Efficacy and Safety of New-Generation Intense Pulsed Light in the Treatment of Meibomian Gland Dysfunction-Related Dry Eye: A Multicenter, Randomized, Patients-Blind, Parallel-Control, Non-Inferiority Clinical Trial |
title_sort | efficacy and safety of new-generation intense pulsed light in the treatment of meibomian gland dysfunction-related dry eye: a multicenter, randomized, patients-blind, parallel-control, non-inferiority clinical trial |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9437192/ https://www.ncbi.nlm.nih.gov/pubmed/35974296 http://dx.doi.org/10.1007/s40123-022-00556-1 |
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