Myopia Control With the Multi-segment Lens

Myopia Clinical Trial

Official title:

The Clinical Trial of Myopia Control in Schoolchildren Using the Multi-segment (MS) Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206217
• Other study ID #: H-ZG3B
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: July 2017

Study information

• Verified date: June 2020
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the Multiple-Segment (MS) spectacle lens can slow myopia progression in Hong Kong schoolchildren.

MS lens is also called Defocus Incorporated Multiple Segments (DIMS) spectacle lens

Description:

MS lens is a novel lens designed in attempt to slow myopia progression. It is a multifocal spectacle lens which corrects distance refractive error and at the same time produces myopic defocus images on the retina for all distances. The myopic defocus aims at slowing down myopia progression. The purpose of this study is to investigate if the MS lens can slow myopia progression in Hong Kong Chinese schoolchildren. The subjects will be randomly assigned to either treatment group (wear MS lenses) or control group (wear ordinary single vision lenses). Their cycloplegic refraction and axial length will be monitored every six months over 2 years. The changes in refractive errors and axial length in two groups will be compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

Inclusion Criteria:

• Age at enrolment: 8-13 year

• Spherical equivalent refractions (SER): -1.00 to -5.00 Dioptres (D)

• Astigmatism and anisometropia of 1.50 D or less

• Spectacle corrected monocular logMAR visual acuity: 0 or better

• Parents' understanding and acceptance of random allocation of grouping

Exclusion Criteria:

• any ocular and systemic abnormalities might affect visual functions or refractive development

• prior treatment of myopic control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Multiple-Segment spectacle lens
A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression.

Locations

Country	Name	City	State
China	Centre for Myopia Research, The Hong Kong Polytechnic University	Hong Kong
Hong Kong	Centre for Myopia Research, The Hong Kong Polytechnic University	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	HOYA Corporation (Tokyo, Japan)

Countries where clinical trial is conducted

China,  Hong Kong, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycloplegic Refraction Change in SER	Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.	Baseline and 2 years
Secondary	Axial Length	Axial length (mm) was measured after cycloplegia using IOL Master	Baseline and 2 years