Effect of intraocular pressure reduction on progressive high myopia (PHM study): study protocol of a randomised controlled trial

Glaucoma Suspects with High Myopia Study Group; 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; Yizhi Liu; Lin Lv

doi:10.1136/bmjopen-2024-084068

Effect of intraocular pressure reduction on progressive high myopia (PHM study): study protocol of a randomised controlled trial

Glaucoma Suspects with High Myopia Study Group, 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, Yizhi Liu, Lin Lv

Research output: Journal article publication › Journal article › Academic research › peer-review

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.

Keywords: glaucoma; ophthalmology; randomized controlled trial.

Original language	English
Article number	e084068
Pages (from-to)	1-7
Number of pages	7
Journal	BMJ Open
Volume	14
Issue number	6
DOIs	https://doi.org/10.1136/bmjopen-2024-084068
Publication status	Published - 5 Jun 2024

Keywords

glaucoma
ophthalmology
randomized controlled trial

ASJC Scopus subject areas

General Medicine

More information

10.1136/bmjopen-2024-084068

Cite this

Glaucoma Suspects with High Myopia Study Group, Jiang, J., Lin, T., Lin, F., Kong, K., Wang, P., Song, Y., Zhou, F., Wang, Z., Jin, L., Liu, Y., Gao, X., Chen, J., Chen, M., Lam, D. S. C., Jonas, J. B., Chen, S., Zhang, X., Liu, Y., & Lv, L. (2024). Effect of intraocular pressure reduction on progressive high myopia (PHM study): study protocol of a randomised controlled trial. BMJ Open, 14(6), 1-7. Article e084068. https://doi.org/10.1136/bmjopen-2024-084068

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title = "Effect of intraocular pressure reduction on progressive high myopia (PHM study): study protocol of a randomised controlled trial",

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.Keywords: glaucoma; ophthalmology; randomized controlled trial.",

keywords = "glaucoma, ophthalmology, randomized controlled trial",

author = "{Glaucoma Suspects with High Myopia Study Group} and Jingwen Jiang and Tingting Lin and Fengbin Lin and Kangjie Kong and Peiyuan Wang and Yunhe Song and Fengqi Zhou and Zhenyu Wang and Ling Jin and Yuhong Liu and Xinbo Gao and Jinmei Chen and Meiling Chen and Lam, {Dennis S. C.} and Jonas, {Jost B.} and Shida Chen and Xiulan Zhang and Yizhi Liu and Lin Lv and David Friedman and Ting Aung and Wei Wang and Fei Li and Kai Gao and Bressler, {Neil M.} and Park, {Ki Ho} and Mingguang He and Kyoko Ohno-Matsui and Weinreb, {Robert N.} and Ching-Yu Cheng and Paul Healey and Zangwill, {Linda M.} and Xiang Chen and Guangxian Tang",

note = "Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2024",

month = jun,

day = "5",

doi = "10.1136/bmjopen-2024-084068",

language = "English",

volume = "14",

pages = "1--7",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "6",

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Glaucoma Suspects with High Myopia Study Group, Jiang, J, Lin, T, Lin, F, Kong, K, Wang, P, Song, Y, Zhou, F, Wang, Z, Jin, L, Liu, Y, Gao, X, Chen, J, Chen, M, Lam, DSC, Jonas, JB, Chen, S, Zhang, X, Liu, Y & Lv, L 2024, 'Effect of intraocular pressure reduction on progressive high myopia (PHM study): study protocol of a randomised controlled trial', BMJ Open, vol. 14, no. 6, e084068, pp. 1-7. https://doi.org/10.1136/bmjopen-2024-084068

Effect of intraocular pressure reduction on progressive high myopia (PHM study): study protocol of a randomised controlled trial. / Glaucoma Suspects with High Myopia Study Group; Jiang, Jingwen ; Lin, Tingting et al.
In: BMJ Open, Vol. 14, No. 6, e084068, 05.06.2024, p. 1-7.

Research output: Journal article publication › Journal article › Academic research › peer-review

TY - JOUR

T1 - Effect of intraocular pressure reduction on progressive high myopia (PHM study): study protocol of a randomised controlled trial

AU - Glaucoma Suspects with High Myopia Study Group

AU - Jiang, Jingwen

AU - Lin, Tingting

AU - Lin, Fengbin

AU - Kong, Kangjie

AU - Wang, Peiyuan

AU - Song, Yunhe

AU - Zhou, Fengqi

AU - Wang, Zhenyu

AU - Jin, Ling

AU - Liu, Yuhong

AU - Gao, Xinbo

AU - Chen, Jinmei

AU - Chen, Meiling

AU - Lam, Dennis S. C.

AU - Jonas, Jost B.

AU - Chen, Shida

AU - Zhang, Xiulan

AU - Liu, Yizhi

AU - Lv, Lin

AU - Friedman, David

AU - Aung, Ting

AU - Wang, Wei

AU - Li, Fei

AU - Gao, Kai

AU - Bressler, Neil M.

AU - Park, Ki Ho

AU - He, Mingguang

AU - Ohno-Matsui, Kyoko

AU - Weinreb, Robert N.

AU - Cheng, Ching-Yu

AU - Healey, Paul

AU - Zangwill, Linda M.

AU - Chen, Xiang

AU - Tang, Guangxian

PY - 2024/6/5

Y1 - 2024/6/5

N2 - 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.Keywords: glaucoma; ophthalmology; randomized controlled trial.

AB - 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.Keywords: glaucoma; ophthalmology; randomized controlled trial.

KW - glaucoma

KW - ophthalmology

KW - randomized controlled trial

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U2 - 10.1136/bmjopen-2024-084068

DO - 10.1136/bmjopen-2024-084068

M3 - Journal article

SN - 2044-6055

VL - 14

SP - 1

EP - 7

JO - BMJ Open

JF - BMJ Open

IS - 6

M1 - e084068

ER -

Effect of intraocular pressure reduction on progressive high myopia (PHM study): study protocol of a randomised controlled trial

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