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Verfasst von:Jiang, Jingwen [VerfasserIn]   i
 Lin, Tingting [VerfasserIn]   i
 Lin, Fengbin [VerfasserIn]   i
 Kong, Kangjie [VerfasserIn]   i
 Wang, Peiyuan [VerfasserIn]   i
 Song, Yunhe [VerfasserIn]   i
 Zhou, Fengqi [VerfasserIn]   i
 Wang, Zhenyu [VerfasserIn]   i
 Jin, Ling [VerfasserIn]   i
 Liu, Yuhong [VerfasserIn]   i
 Gao, Xinbo [VerfasserIn]   i
 Chen, Jinmei [VerfasserIn]   i
 Chen, Meiling [VerfasserIn]   i
 Lam, Dennis S. C. [VerfasserIn]   i
 Jonas, Jost B. [VerfasserIn]   i
 Chen, Shida [VerfasserIn]   i
 Zhang, Xiulan [VerfasserIn]   i
Titel:Effect of intraocular pressure reduction on progressive high myopia (PHM study)
Titelzusatz:study protocol of a randomised controlled trial
Verf.angabe:Jingwen Jiang, Tingting Lin, Fengbin Lin, Kangjie Kong, Peiyuan Wang, Yunhe Song, Fengqi Zhou, Zhenyu Wang, Ling Jin, Yuhong Liu, Xinbo Gao, Jinmei Chen, Meiling Chen, Dennis S. C. Lam, Jost B. Jonas, Shida Chen, Xiulan Zhang, for the Glaucoma Suspects with High Myopia Study Group
E-Jahr:2024
Jahr:5 June 2024
Umfang:7 S.
Fussnoten:Gesehen am 30.01.2025
Titel Quelle:Enthalten in: BMJ open
Ort Quelle:London : BMJ Publishing Group, 2011
Jahr Quelle:2024
Band/Heft Quelle:14(2024), 6 vom: Mai, Artikel-ID e084068, Seite 1-7
ISSN Quelle:2044-6055
Abstract:BACKGROUND: In adult patients with high myopia (HM), progressive axial elongation poses a significant risk for the development of subsequent ocular complications that may lead to visual impairment. Effective strategies to reduce or prevent further axial elongation in highly myopic adult patients have not been available so far. Recent studies suggested that medically lowering intraocular pressure (IOP) may reduce axial elongation. - OBJECTIVE: This clinical randomised controlled trial (RCT) aims to evaluate the efficacy of medical IOP reduction in adult patients with progressive HM (PHM). - TRIAL DESIGN: Single-centre, open-label, prospective RCT. - METHODS: This RCT will recruit 152 participants with PHM at the Zhongshan Ophthalmic Center (ZOC). Randomised in a ratio of 1:1, participants will receive IOP-lowering eyedrops (intervention group) or will be followed without treatment (control group) for 12 months. Follow-up visits will be conducted at 1, 6 and 12 months after baseline. Only one eye per eligible participant will be included for analysis. The primary outcome is the change in axial length (AL) within the study period of 12 months. Secondary outcomes include the incidence and progression of visual field (VF) defects, changes in optic disc morphology and incidence and progression of myopic maculopathy. Difference in AL changes between the two groups will be analysed using linear regression analysis. For the secondary outcomes, a multifactor Poisson regression within a generalised linear model will be used to estimate the relative risk of progression in VF defects and myopic maculopathy, and the rate of thinning in retinal nerve fibre layer and ganglion cell-inner plexiform will be assessed through Kaplan-Meier curves and log-rank tests. - ETHICS AND DISSEMINATION: Full ethics approval for this trial has been obtained from the Ethics Committee of ZOC, Sun Yat-sen University, China (ID: 2023KYPJ110). Results of this trial will be disseminated through peer-reviewed journals and conference presentations. - TRIAL REGISTRATION NUMBER: NCT05850936.
DOI:doi:10.1136/bmjopen-2024-084068
URL:Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.

kostenfrei: Volltext: https://doi.org/10.1136/bmjopen-2024-084068
 DOI: https://doi.org/10.1136/bmjopen-2024-084068
Datenträger:Online-Ressource
Sprache:eng
Sach-SW:Adult
 Axial Length, Eye
 Disease Progression
 Female
 glaucoma
 Humans
 Intraocular Pressure
 Male
 Middle Aged
 Myopia, Degenerative
 Ophthalmic Solutions
 ophthalmology
 Prospective Studies
 randomized controlled trial
 Randomized Controlled Trials as Topic
 Visual Fields
K10plus-PPN:1916020046
Verknüpfungen:→ Zeitschrift

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