Efficacy and Safety of the New Defocus Spectacle Lens in Preventing Progression of Myopia

NCT05740904 | Completed

• 1 other identifier: 2023KYPJ006
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical effects of new technical spectacles with refractive correction function are mixed. A randomised trial is designed to compare the effects of new defocusing spectacle lenses and traditional aspheric spectacle lenses on myopia progression in Chinese children aged 6-14 years.

Conditions

Myopia

Keywords

Defocused lens; Myopia control

Outcome Measures

Primary Outcomes (1)

• Changes of spherical equivalent refraction (SER) at one year

  The difference of SER (Diopter) at one year compared with baseline SER. SER will be measured after cycloplegia.

  1 year

Secondary Outcomes (11)

• Changes of axial length (AL) at one year

  1 year

• Change of anterior chamber depth (ACD) at one year

  1 year

• Change of lens thickness (LT) at one year

  1 year

• Change of corneal power (CP) at one year

  1 year

• Best corrected visual acuity（BCVA） at one year

  1 year

Study Arms (2)

New defocus spectacle lens

EXPERIMENTAL

The children in the experimental group will wear new defocus spectacle lens and receive follow-up examinations every half year.

Other: New defocus spectacle lenses

Conventional aspheric single-vision spectacle lenses

ACTIVE COMPARATOR

The children in the control group will wear conventional aspheric single-vision spectacles and receive follow-up examinations every half year.

Other: Convenional aspheric single-vision spectacle lenses

Interventions

New defocus spectacle lenses OTHER

The children in the new defocus spectacle lens group will wear new defocus spectacle and receive follow-up examinations every half year.

New defocus spectacle lens

Convenional aspheric single-vision spectacle lenses OTHER

The children in the convenional aspheric spectacle lenses group will wear conventional aspheric single-vision spectacle and receive follow-up examinations every half year.

Conventional aspheric single-vision spectacle lenses

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6 to 14 years;
• Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -1.00 to -3.50 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.00 D;
• Best-corrected visual acuity of equal or better than 0.00 LogMAR (\>= 1.0 as Snellen).
• The intraocular pressure of 10 to 21mmHg.
• Volunteer to participate in this clinical trial with signature of the informed consent form.

You may not qualify if:

• History of eye injury or intraocular surgery;
• Clinically abnormal slit-lamp findings
• Abnormal fundus examination
• Ocular disease, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function;
• Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);
• Participation of the drug clinical trial within three month and the device clinical trial within one month;
• Unable to have regular follow-up
• Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursing products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (8)

• GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Trends in prevalence of blindness and distance and near vision impairment over 30 years: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021 Feb;9(2):e130-e143. doi: 10.1016/S2214-109X(20)30425-3. Epub 2020 Dec 1.

  PMID: 33275950 BACKGROUND

• Burton MJ, Ramke J, Marques AP, Bourne RRA, Congdon N, Jones I, Ah Tong BAM, Arunga S, Bachani D, Bascaran C, Bastawrous A, Blanchet K, Braithwaite T, Buchan JC, Cairns J, Cama A, Chagunda M, Chuluunkhuu C, Cooper A, Crofts-Lawrence J, Dean WH, Denniston AK, Ehrlich JR, Emerson PM, Evans JR, Frick KD, Friedman DS, Furtado JM, Gichangi MM, Gichuhi S, Gilbert SS, Gurung R, Habtamu E, Holland P, Jonas JB, Keane PA, Keay L, Khanna RC, Khaw PT, Kuper H, Kyari F, Lansingh VC, Mactaggart I, Mafwiri MM, Mathenge W, McCormick I, Morjaria P, Mowatt L, Muirhead D, Murthy GVS, Mwangi N, Patel DB, Peto T, Qureshi BM, Salomao SR, Sarah V, Shilio BR, Solomon AW, Swenor BK, Taylor HR, Wang N, Webson A, West SK, Wong TY, Wormald R, Yasmin S, Yusufu M, Silva JC, Resnikoff S, Ravilla T, Gilbert CE, Foster A, Faal HB. The Lancet Global Health Commission on Global Eye Health: vision beyond 2020. Lancet Glob Health. 2021 Apr;9(4):e489-e551. doi: 10.1016/S2214-109X(20)30488-5. Epub 2021 Feb 16. No abstract available.

  PMID: 33607016 BACKGROUND

• He M, Xiang F, Zeng Y, Mai J, Chen Q, Zhang J, Smith W, Rose K, Morgan IG. Effect of Time Spent Outdoors at School on the Development of Myopia Among Children in China: A Randomized Clinical Trial. JAMA. 2015 Sep 15;314(11):1142-8. doi: 10.1001/jama.2015.10803.

  PMID: 26372583 BACKGROUND

• Hoseini-Yazdi H, Vincent SJ, Read SA, Collins MJ. Astigmatic Defocus Leads to Short-Term Changes in Human Choroidal Thickness. Invest Ophthalmol Vis Sci. 2020 Jul 1;61(8):48. doi: 10.1167/iovs.61.8.48.

  PMID: 32729913 BACKGROUND

• Kanda H, Oshika T, Hiraoka T, Hasebe S, Ohno-Matsui K, Ishiko S, Hieda O, Torii H, Varnas SR, Fujikado T. Effect of spectacle lenses designed to reduce relative peripheral hyperopia on myopia progression in Japanese children: a 2-year multicenter randomized controlled trial. Jpn J Ophthalmol. 2018 Sep;62(5):537-543. doi: 10.1007/s10384-018-0616-3. Epub 2018 Aug 6.

  PMID: 30083910 BACKGROUND

• Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020 Mar;104(3):363-368. doi: 10.1136/bjophthalmol-2018-313739. Epub 2019 May 29.

  PMID: 31142465 BACKGROUND

• Yam JC, Zhang XJ, Zhang Y, Wang YM, Tang SM, Li FF, Kam KW, Ko ST, Yip BHK, Young AL, Tham CC, Chen LJ, Pang CP. Three-Year Clinical Trial of Low-Concentration Atropine for Myopia Progression (LAMP) Study: Continued Versus Washout: Phase 3 Report. Ophthalmology. 2022 Mar;129(3):308-321. doi: 10.1016/j.ophtha.2021.10.002. Epub 2021 Oct 7.

  PMID: 34627809 BACKGROUND

• Zhang HY, Lam CSY, Tang WC, Leung M, To CH. Defocus Incorporated Multiple Segments Spectacle Lenses Changed the Relative Peripheral Refraction: A 2-Year Randomized Clinical Trial. Invest Ophthalmol Vis Sci. 2020 May 11;61(5):53. doi: 10.1167/iovs.61.5.53.

  PMID: 32460315 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Yangfa Zeng

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 23, 2023
• Study Start: March 23, 2023
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: January 23, 2025

Record last verified: 2024-03

Locations

CN (1)