NCT02206217

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

July 31, 2019

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

2.9 years

First QC Date

July 29, 2014

Results QC Date

May 16, 2018

Last Update Submit

June 15, 2020

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Axial Length

    Baseline and 2 years

Study Arms (2)

Single vision spectacle lens

NO INTERVENTION

Single vision lens with power for correcting distance refraction.

Multiple-Segment spectacle lens

EXPERIMENTAL

A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time.

Device: Multiple-Segment spectacle lens

Interventions

Multiple-Segment spectacle lensDEVICE

A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression.

Also known as: MS lens
Multiple-Segment spectacle lens

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for Myopia Research, The Hong Kong Polytechnic University

Hong Kong, China

Location

Centre for Myopia Research, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (3)

  • 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: 31142465RESULT

  • Chun RKM, Zhang H, Liu Z, Tse DYY, Zhou Y, Lam CSY, To CH. Defocus incorporated multiple segments (DIMS) spectacle lenses increase the choroidal thickness: a two-year randomized clinical trial. Eye Vis (Lond). 2023 Sep 15;10(1):39. doi: 10.1186/s40662-023-00356-z.

    PMID: 37715201DERIVED

  • Lam CSY, Tang WC, Zhang HY, Lee PH, Tse DYY, Qi H, Vlasak N, To CH. Long-term myopia control effect and safety in children wearing DIMS spectacle lenses for 6 years. Sci Rep. 2023 Apr 4;13(1):5475. doi: 10.1038/s41598-023-32700-7.

    PMID: 37015996DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Prof. Carly Sin Yin Lam
Organization
School of Optometry, The Hong Kong Polytechnic University
carly.lam@polyu.edu.hk
2766 6091

Study Officials

  • Carly SY Lam, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

  • Chi ho To, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 29, 2014

First Posted

August 1, 2014

Study Start

August 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 2, 2020

Results First Posted

July 31, 2019

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)HK(1)