Effectiveness and Safety of Partition Multi-point Defocused Myopia Management Spectacle Lens in Myopia Control

Myopia Clinical Trial

Official title:

Effectiveness and Safety of Partition Multi-point Defocused Myopia Management Spectacle Lens in Myopia Control Compared With Spectacle Lenses With Aspherical Lenslets: a Randomised Non-inferiority Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05740930
• Other study ID #: 2023KYPJ004
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Myopia is considered to be the most common type of refractive error, and the incidence of myopia has shown a trend of low age. Recent studies found that the new aspheric microlens spectacle lens can more effectively control the progress of diopter than the single-vision spectcale lens. A new technology of equivalent defocusing around the lens called the partition multi-point defocus optical technology is adopted in this study.

Description:

Myopia is considered to be the most common type of refractive error, and it has increased rapidly worldwide. The vision damage caused by uncorrected myopia seriously affects the quality of life, may lead to poor academic performance of children, and cause considerable economic burden. About 90% of vision damage caused by myopia can be prevented by cost-effective interventions or treatment.

In recent years, the incidence of myopia has shown a trend of low age. Therefore, clinical intervention should be carried out in the childhood stage, which is the key period of eye development, to control the progress of myopia. A recent 2-year randomized controlled study in China found that the new aspheric microlens myopia control spectacle lens can more effectively control the progress of diopter than the single-vision spectcale lens. Different studies have found or proved the technical principle of the new aspheric defocusing microlens.

Animal experiments found that the direction, intensity and regional distribution of optical defocus signals have a substantial impact on the growth of eyes; The diopter of peripheral relative hyperopia can affect the central myopia; The changes of myopia and optical defocus in the nasal and temporal regions can change the shape and peripheral refraction of the eyes; Local changes in the effective focus of the eye will lead to regional changes in eye growth and refractive error. Based on the findings of animal experiments, the new technology of equivalent defocusing around the lens called the partition multi-point defocus optical technology is adopted in this study.

A prospective, single-center, open-label, non-inferiority randomized controlled trial is developed to evaluate the effectiveness and safety of partition multi-point defocused myopia management spectacle lens among children in China in myopia control.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 194
• Est. completion date: June 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

Inclusion Criteria:

• Aged 8 to 13 years;

• Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -0.75 to -4.75 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.

Exclusion Criteria:

• 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;

• Only one eye meets the inclusion criteria;

• 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.

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• Partition defocus myopia management spectacle lens
Participants in the intervention group will receive the partition defocus myopia management spectacles lens and receive follow-up checks.
• Spectacle lenses with aspherical lenslets
Participants in the control group will receive the spectacle lenses with aspherical lenslets and receive follow-up checks.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (13)

Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2. — View Citation

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. — View Citation

Fricke TR, Holden BA, Wilson DA, Schlenther G, Naidoo KS, Resnikoff S, Frick KD. Global cost of correcting vision impairment from uncorrected refractive error. Bull World Health Organ. 2012 Oct 1;90(10):728-38. doi: 10.2471/BLT.12.104034. Epub 2012 Jul 12. — View Citation

He M, Zheng Y, Xiang F. Prevalence of myopia in urban and rural children in mainland China. Optom Vis Sci. 2009 Jan;86(1):40-4. doi: 10.1097/OPX.0b013e3181940719. — View Citation

Huang J, Hung LF, Smith EL 3rd. Recovery of peripheral refractive errors and ocular shape in rhesus monkeys (Macaca mulatta) with experimentally induced myopia. Vision Res. 2012 Nov 15;73:30-9. doi: 10.1016/j.visres.2012.09.002. Epub 2012 Sep 28. — View Citation

Modjtahedi BS, Abbott RL, Fong DS, Lum F, Tan D; Task Force on Myopia. Reducing the Global Burden of Myopia by Delaying the Onset of Myopia and Reducing Myopic Progression in Children: The Academy's Task Force on Myopia. Ophthalmology. 2021 Jun;128(6):816-826. doi: 10.1016/j.ophtha.2020.10.040. Epub 2020 Dec 30. — View Citation

Naidoo KS, Fricke TR, Frick KD, Jong M, Naduvilath TJ, Resnikoff S, Sankaridurg P. Potential Lost Productivity Resulting from the Global Burden of Myopia: Systematic Review, Meta-analysis, and Modeling. Ophthalmology. 2019 Mar;126(3):338-346. doi: 10.1016/j.ophtha.2018.10.029. Epub 2018 Oct 17. — View Citation

Rose K, Harper R, Tromans C, Waterman C, Goldberg D, Haggerty C, Tullo A. Quality of life in myopia. Br J Ophthalmol. 2000 Sep;84(9):1031-4. doi: 10.1136/bjo.84.9.1031. — View Citation

Smith EL 3rd, Hung LF, Huang J, Arumugam B. Effects of local myopic defocus on refractive development in monkeys. Optom Vis Sci. 2013 Nov;90(11):1176-86. doi: 10.1097/OPX.0000000000000038. — View Citation

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 Aug;51(8):3864-73. doi: 10.1167/iovs.09-4969. Epub 2010 Mar 10. — View Citation

Smith EL 3rd, Hung LF. The role of optical defocus in regulating refractive development in infant monkeys. Vision Res. 1999 Apr;39(8):1415-35. doi: 10.1016/s0042-6989(98)00229-6. — View Citation

Wallman J, Gottlieb MD, Rajaram V, Fugate-Wentzek LA. Local retinal regions control local eye growth and myopia. Science. 1987 Jul 3;237(4810):73-7. doi: 10.1126/science.3603011. — View Citation

Wildsoet CF, Chia A, Cho P, Guggenheim JA, Polling JR, Read S, Sankaridurg P, Saw SM, Trier K, Walline JJ, Wu PC, Wolffsohn JS. IMI - Interventions Myopia Institute: Interventions for Controlling Myopia Onset and Progression Report. Invest Ophthalmol Vis Sci. 2019 Feb 28;60(3):M106-M131. doi: 10.1167/iovs.18-25958. Erratum In: Invest Ophthalmol Vis Sci. 2019 Apr 1;60(5):1768. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of spherical equivalent refraction (SER) at two years	The difference of SER (Diopter) at two years from baseline. SER will be measured every year after cycloplegia.	2 years
Secondary	Changes of axial length (AL) at two years	The difference of AL (mm) at two years from baseline. AL will be measured every half year by IOLMaster700.	2 years
Secondary	Change of anterior chamber depth (ACD) at two years	The difference of ACD(mm) at two years from baseline. ACD will be measured every half year by IOLMaster700.	2 years
Secondary	Change of lens thickness (LT) at two years	The difference of LT (mm) at two years from baseline. LT will be measured every half year by IOLMaster700.	2 years
Secondary	Change of corneal power (CP) at two years	The difference of CP (Diopter) at two years from baseline. CP will be measured every half year by IOLMaster700.	2 years
Secondary	Best corrected visual acuity at two years	Best corrected visual acuity measured every year by EDTRS visual acuity chart after cycloplegia.	2 years
Secondary	Binocular visual function at two years	Binocular visual function which will be measured every year is a qualitative outcome assessed by a series of tests.	2 years
Secondary	Choroidal thickness at two years	The difference of Choroidal thickness (µm) at two years from baseline. Choroidal thickness will be measured every year by OCTA.	2 years
Secondary	Visual scale score at six months	Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2) and scaled from 0 (poor quality of life) to 100 (good quality of life).	6 months
Secondary	Visual scale score at two years	Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2) and scaled from 0 (poor quality of life) to 100 (good quality of life).	2 years
Secondary	Time length of wearing spectcales at two years	Time length of wearing spectcales collected every half year. Participants report the approximate time of wearing glasses per day and the days of wearing glasses per week.	2 years
Secondary	Safty of wearing the spectacle lens	Safty of wearing the spectacle lens which is a qualitative outcome will be evaluated every half year by prespecified measures and definations based on symptoms and signs, intraocular pressure,slit lamp and ocular fundus checks.	2 years