Myopia Control With the Multi-segment Lens

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02206217
• Collaborator: HOYA Corporation (Tokyo, Japan) (Other)
• Enrollment: 183
• Locations: 2
• Arms: 2
• Actual Duration (Months): 35
• Patients Per Site: 91.5
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Multiple-Segment spectacle lens	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Clinical Trial of Myopia Control in Schoolchildren Using the Multi-segment (MS) Lens
• Actual Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Single vision spectacle lens Single vision lens with power for correcting distance refraction.
Experimental: Multiple-Segment spectacle lens A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time.	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.; Other Names: MS lens

Outcome Measures

Primary Outcome Measures

1. Cycloplegic Refraction Change in SER [Baseline and 2 years]

   Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.

Secondary Outcome Measures

1. Axial Length [Baseline and 2 years]

   Axial length (mm) was measured after cycloplegia using IOL Master

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Myopia Research, The Hong Kong Polytechnic University	Hong Kong		China
2	Centre for Myopia Research, The Hong Kong Polytechnic University	Hong Kong		Hong Kong

Sponsors and Collaborators

• The Hong Kong Polytechnic University
• HOYA Corporation (Tokyo, Japan)

Investigators

• Principal Investigator: Carly SY Lam, PhD, The Hong Kong Polytechnic University
• Principal Investigator: Chi ho To, PhD, The Hong Kong Polytechnic University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 25, 2014

More Information

Publications

None provided.

• Responsible Party: Carly Lam, Professor, The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT02206217
• Other Study ID Numbers: H-ZG3B
• First Posted: Aug 1, 2014
• Last Update Posted: Jul 2, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Single Vision Spectacle Lens	Multiple-Segment Spectacle Lens
Arm/Group Description	Single vision lens with power for correcting distance refraction.	A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time. 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.
Period Title: Overall Study
STARTED	90	93
COMPLETED	81	79
NOT COMPLETED	9	14

Baseline Characteristics

Arm/Group Title	Single Vision Spectacle Lens	Multiple-Segment Spectacle Lens	Total
Arm/Group Description	Single vision lens with power for correcting distance refraction.	A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time. 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.	Total of all reporting groups
Overall Participants	90	93	183
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.01 (1.44)	10.19 (1.46)	10.09 (1.45)
Sex: Female, Male (Count of Participants)
Female	40 44.4%	38 40.9%	78 42.6%
Male	50 55.6%	55 59.1%	105 57.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	90 100%	93 100%	183 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Hong Kong	90 100%	93 100%	183 100%
cycloplegic spherical equivalent refraction (SER) (Diopters (D)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Diopters (D)]	-2.69 (0.98)	-2.92 (1.09)	-2.81 (1.01)
Axial length (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	24.62 (0.82)	24.85 (1.59)	24.74 (1.27)

Outcome Measures

1. Primary Outcome

Title	Cycloplegic Refraction Change in SER
Description	Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

completed 2-year study

Arm/Group Title	SV Group	MS Group
Arm/Group Description	single vision spectacle lens	Multi-segment lens (or called DIMS lens)
Measure Participants	81	79
Mean (Standard Deviation) [Diopters (D)]	-0.93 (0.58)	-0.38 (0.53)

2. Secondary Outcome

Title	Axial Length
Description	Axial length (mm) was measured after cycloplegia using IOL Master
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

completed 2-year study

Arm/Group Title	SV Group	MS Group
Arm/Group Description	single vision spectacle lens	Multi-segment lens (or called DIMS lens)
Measure Participants	81	79
Mean (Standard Deviation) [mm]	0.53 (0.24)	0.21 (0.22)

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	Interventions were only spectacles, not drug or surgery. The subjects only wore spectacle lenses and had regular routine eye examination that the particpants rarely had risk of adverse events.
Arm/Group Title	SV Group		MS Group
Arm/Group Description	single vision spectacle lens		Multi-segment lens (or called DIMS lens)
All Cause Mortality
	SV Group		MS Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		0/93 (0%)
Serious Adverse Events
	SV Group		MS Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		0/93 (0%)
Other (Not Including Serious) Adverse Events
	SV Group		MS Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		0/93 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.