Myopia
Conditions
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
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.
Interventions
DEVICEMultiple-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.
Sponsors
HOYA Corporation (Tokyo, Japan)
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Axial Length | Baseline and 2 years | Axial length (mm) was measured after cycloplegia using IOL Master |
Countries
China, Hong Kong
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Vision Spectacle Lens Single vision lens with power for correcting distance refraction. | 90 |
| Multiple-Segment Spectacle Lens 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. | 93 |
| Total | 183 |
Baseline characteristics
| Characteristic | Single Vision Spectacle Lens | Multiple-Segment Spectacle Lens | Total |
|---|---|---|---|
| Age, Continuous | 10.01 years STANDARD_DEVIATION 1.44 | 10.19 years STANDARD_DEVIATION 1.46 | 10.09 years STANDARD_DEVIATION 1.45 |
| Axial length | 24.62 mm STANDARD_DEVIATION 0.82 | 24.85 mm STANDARD_DEVIATION 1.59 | 24.74 mm STANDARD_DEVIATION 1.27 |
| cycloplegic spherical equivalent refraction (SER) | -2.69 Diopters (D) STANDARD_DEVIATION 0.98 | -2.92 Diopters (D) STANDARD_DEVIATION 1.09 | -2.81 Diopters (D) STANDARD_DEVIATION 1.01 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 90 Participants | 93 Participants | 183 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Hong Kong | 90 Participants | 93 Participants | 183 Participants |
| Sex: Female, Male Female | 40 Participants | 38 Participants | 78 Participants |
| Sex: Female, Male Male | 50 Participants | 55 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 93 |
| other Total, other adverse events | 0 / 90 | 0 / 93 |
| serious Total, serious adverse events | 0 / 90 | 0 / 93 |
Outcome results
Primary
Cycloplegic Refraction Change in SER
Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.
Time frame: Baseline and 2 years
Population: completed 2-year study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SV Group | Cycloplegic Refraction Change in SER | -0.93 Diopters (D) | Standard Deviation 0.58 |
| MS Group | Cycloplegic Refraction Change in SER | -0.38 Diopters (D) | Standard Deviation 0.53 |
Secondary
Axial Length
Axial length (mm) was measured after cycloplegia using IOL Master
Time frame: Baseline and 2 years
Population: completed 2-year study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SV Group | Axial Length | 0.53 mm | Standard Deviation 0.24 |
| MS Group | Axial Length | 0.21 mm | Standard Deviation 0.22 |