Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2023

Open Access 01-12-2023 | Study protocol

Effect of wearing peripheral focus-out glasses on emmetropization in Chinese children aged 6–8 years: study protocol for a 2-year randomized controlled intervention trial

Authors: Li Shen, Wennan He, Weiming Yang, Weili Yan, Chenhao Yang

Published in: Trials | Issue 1/2023

Login to get access

Abstract

Background

Myopia is one of the most common eye diseases causing visual impairment and blindness, and the high prevalence in adolescents remains a major public health concern. Based on clinical studies using optical defocus to regulate ocular growth and refractive changes through visual feedback, we hypothesize that early wearing of peripheral myopic defocusing spectacles in children with high risk of myopia may slow the process of emmetropization and even prevent the onset of myopia by inducing more peripheral myopic defocus. The aim of this study is to investigate whether the wearing of peripheral focus-out glasses can be effective in delaying emmetropization in non-myopic children aged 6–8 years.

Methods

The study is a 2-year randomized controlled trial. A total of 160 subjects will be randomized into the experimental group or the control group. The experimental group will be fitted with direct emmetropia with focus-out glasses (DEFOG) to guide the emmetropization process. The control group will not receive any treatment and will serve as a blank control group. The primary aim is to determine whether non-myopic children wearing DEFOG lenses are superior to those who do not receive any intervention on the progression of cycloplegic objective refraction over 2 years.

Discussion

This is the first randomized controlled trial aiming at myopic prevention by non-invasive intervention in non-myopic children. This study aims to initially investigate whether wearing peripheral focus-out glasses can effectively delay the process of emmetropization in children aged 6–8 years with high risk of myopia, which might give potential clues for further exploration on early prevention of myopia.

Trial registration

ClinicalTrials.gov NCT05689567. Registered on 10 January 2023.
Appendix
Available only for authorised users
Literature
1.
Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, et al. Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology. 2016;123(5):1036–42.CrossRefPubMed
2.
Saunders KJ, Woodhouse JM, Westall CA. Emmetropisation in human infancy: rate of change is related to initial refractive error. Vision Res. 1995;35(9):1325–8.CrossRefPubMed
3.
Smith EL 3rd, Hung LF. The role of optical defocus in regulating refractive development in infant monkeys. Vision Res. 1999;39(8):1415–35.CrossRefPubMed
4.
Wang J, Ying GS, Fu X, Zhang R, Meng J, Gu F, et al. Prevalence of myopia and vision impairment in school students in Eastern China. BMC Ophthalmol. 2020;20(1):2.CrossRefPubMedPubMedCentral
5.
Smith EL 3rd, Hung LF, Huang J, Blasdel TL, Humbird TL, Bockhorst KH. Effects of optical defocus on refractive development in monkeys: evidence for local, regionally selective mechanisms. Invest Ophthalmol Vis Sci. 2010;51(8):3864–73.CrossRefPubMedPubMedCentral
6.
Smith EL 3rd, Kee CS, Ramamirtham R, Qiao-Grider Y, Hung LF. Peripheral vision can influence eye growth and refractive development in infant monkeys. Invest Ophthalmol Vis Sci. 2005;46(11):3965–72.CrossRefPubMed
7.
Walline JJ, Walker MK, Mutti DO, Jones-Jordan LA, Sinnott LT, Giannoni AG, et al. Effect of high add power, medium add power, or single-vision contact lenses on myopia progression in children. JAMA. 2020;324(6):571–80.CrossRefPubMedPubMedCentral
8.
Lam CS, Tang WC, Lee PH, Zhang HY, Qi H, Hasegawa K, et al. Myopia control effect of defocus incorporated multiple segments (DIMS) spectacle lens in Chinese children: results of a 3-year follow-up study. Br J Ophthalmol. 2022;106(8):1110–4.PubMed
9.
Yam JC, Jiang Y, Tang SM, Law AKP, Chan JJ, Wong E, et al. Low-concentration Atropine for Myopia Progression (LAMP) study: a randomized, double-blinded, placebo-controlled trial of 0.05%, 0.025%, and 0.01% atropine eye drops in myopia control. Ophthalmology. 2019;126(1):113–24.CrossRefPubMed
10.
Hiraoka T, Kakita T, Okamoto F, Takahashi H, Oshika T. Long-term effect of overnight orthokeratology on axial length elongation in childhood myopia: a 5-year follow-up study. Invest Ophthalmol Vis Sci. 2012;53(7):3913–9.CrossRefPubMed
11.
Chamberlain P, Peixoto-de-Matos SC, Logan NS, Ngo C, Jones D, Young G. A 3-year randomized clinical trial of MiSight lenses for myopia control. Optom Vis Sci. 2019;96(8):556–67.CrossRefPubMed
12.
He X, Wang J, Zhu Z, Xiang K, Zhang X, Zhang B, et al. Effect of repeated low-level red light on myopia prevention among children in China with premyopia: a randomized clinical trial. JAMA Netw Open. 2023;6(4):e239612.CrossRefPubMedPubMedCentral
13.
Liu H, Yang Y, Guo J, Peng J, Zhao P. Retinal damage after repeated low-level red-light laser exposure. JAMA Ophthalmol. 2023;141(7):693–5.CrossRefPubMed
14.
He X, Sankaridurg P, Xiong S, Li W, Naduvilath T, Lin S, et al. Prevalence of myopia and high myopia, and the association with education: Shanghai Child and Adolescent Large-scale Eye Study (SCALE): a cross-sectional study. BMJ Open. 2021;11(12):e048450.CrossRefPubMedPubMedCentral
15.
Wildsoet CF, Chia A, Cho P, Guggenheim JA, Polling JR, Read S, et al. IMI - Interventions Myopia Institute: interventions for controlling myopia onset and progression report. Invest Ophthalmol Vis Sci. 2019;60(3):M106–31.CrossRefPubMed
16.
Wolffsohn JS, Kollbaum PS, Berntsen DA, Atchison DA, Benavente A, Bradley A, et al. IMI - Clinical myopia control trials and instrumentation report. Invest Ophthalmol Vis Sci. 2019;60(3):M132–60.CrossRefPubMed
17.
Jiang Y, Zhu Z, Tan X, Kong X, Zhong H, Zhang J, et al. Effect of repeated low-level red-light therapy for myopia control in children: a multicenter randomized controlled trial. Ophthalmology. 2022;129(5):509–19.CrossRefPubMed
18.
He X, Sankaridurg P, Wang J, Chen J, Naduvilath T, He M, et al. Time outdoors in reducing myopia: a school-based cluster randomized trial with objective monitoring of outdoor time and light intensity. Ophthalmology. 2022;129(11):1245–54.CrossRefPubMed
19.
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral
20.
Lam CS, Lam CH, Cheng SC, Chan LY. Prevalence of myopia among Hong Kong Chinese schoolchildren: changes over two decades. Ophthalmic Physiol Opt. 2012;32(1):17–24.CrossRefPubMed
21.
Ma Y, Qu X, Zhu X, Xu X, Zhu J, Sankaridurg P, et al. Age-specific prevalence of visual impairment and refractive error in children aged 3–10 years in Shanghai. China Invest Ophthalmol Vis Sci. 2016;57(14):6188–96.CrossRefPubMed
22.
You QS, Wu LJ, Duan JL, Luo YX, Liu LJ, Li X, et al. Prevalence of myopia in school children in greater Beijing: the Beijing Childhood Eye Study. Acta Ophthalmol. 2014;92(5):e398-406.CrossRefPubMed
23.
Ma Y, Lin S, Morgan IG, Rozema JJ, Iribarren R, Zhu J, et al. Eyes grow towards mild hyperopia rather than emmetropia in Chinese preschool children. Acta Ophthalmol. 2021;99(8):e1274–80.CrossRefPubMedPubMedCentral
24.
Wang J, Han Y, Musch DC, Li Y, Wei N, Qi X, et al. Evaluation and follow-up of myopia prevalence among school-aged children subsequent to the COVID-19 home confinement in Feicheng. China JAMA Ophthalmol. 2023;141(4):333–40.CrossRefPubMed
25.
He M, Xiang F, Zeng Y, Mai J, Chen Q, Zhang J, et al. Effect of time spent outdoors at school on the development of myopia among children in China: a randomized clinical trial. JAMA. 2015;314(11):1142–8.CrossRef
26.
He X, Sankaridurg P, Xiong S, Li W, Zhang B, Weng R, et al. Shanghai Time Outside to Reduce Myopia trial: design and baseline data. Clin Exp Ophthalmol. 2019;47(2):171–8.CrossRefPubMed
27.
28.
Mutti DO, Hayes JR, Mitchell GL, Jones LA, Moeschberger ML, Cotter SA, et al. Refractive error, axial length, and relative peripheral refractive error before and after the onset of myopia. Invest Ophthalmol Vis Sci. 2007;48(6):2510–9.CrossRefPubMed
Metadata
Title
Effect of wearing peripheral focus-out glasses on emmetropization in Chinese children aged 6–8 years: study protocol for a 2-year randomized controlled intervention trial
Authors
Li Shen
Wennan He
Weiming Yang
Weili Yan
Chenhao Yang
Publication date
01-12-2023
Publisher
BioMed Central
Published in
Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07799-8

Other articles of this Issue 1/2023

Trials 1/2023 Go to the issue

Study protocol

Comparison of posterior muscle-preserving selective laminectomy and laminectomy with fusion for treating cervical spondylotic myelopathy: study protocol for a randomized controlled trial

Study protocol

Assessing the effectiveness and cost-effectiveness of a solution-focused resource-orientated approach (DIALOG+) to improving the quality of life for people with psychosis in India and Pakistan—a cluster RCT

Study protocol

A randomised open-label trial to assess outpatient induction of labour (HOMEIND) and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in normal risk nulliparous women: study protocol for a randomised controlled trial

Research

REVISE: re-evaluating the inhibition of stress erosions in the ICU—statistical analysis plan for a randomized trial

Study protocol

Comparing acute normovolumic hemodilution with autologous platelet-rich plasma for blood preservation during aortic surgery : study protocol for a randomized controlled clinical trial

Study protocol

The rationale and study design of two phase II trials examining the effects of BI 685,509, a soluble guanylyl cyclase activator, on clinically significant portal hypertension in patients with compensated cirrhosis