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

NCT05740930 | Completed

• 1 other identifier: 2023KYPJ004
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia

Keywords

Partition multi-point defocused; Myopia control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Changes of axial length (AL) at two years

  2 years

• Change of anterior chamber depth (ACD) at two years

  2 years

• Change of lens thickness (LT) at two years

  2 years

• Change of corneal power (CP) at two years

  2 years

• Best corrected visual acuity at two years

  2 years

Study Arms (2)

Intervention group

EXPERIMENTAL

The participants wear the partition defocus myopia management spectacle lens.

Other: Partition defocus myopia management spectacle lens

Control group

ACTIVE COMPARATOR

spectacle lenses with aspherical lenslets

Other: Spectacle lenses with aspherical lenslets

Interventions

Partition defocus myopia management spectacle lens OTHER

Participants in the intervention group will receive the partition defocus myopia management spectacles lens and receive follow-up checks.

Intervention group

Spectacle lenses with aspherical lenslets OTHER

Participants in the control group will receive the spectacle lenses with aspherical lenslets and receive follow-up checks.

Control group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

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 (13)

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  PMID: 30342076 BACKGROUND

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  PMID: 33811039 BACKGROUND

• 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.

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• 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.

  PMID: 20220051 BACKGROUND

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  PMID: 24061154 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 8, 2023
• First Posted: February 23, 2023
• Study Start: March 20, 2023
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

CN (1)