Trial Outcomes & Findings for Myopia Control With the Multi-segment Lens (NCT NCT02206217)
NCT ID: NCT02206217
Last Updated: 2020-07-02
Results Overview
Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
183 participants
Primary outcome timeframe
Baseline and 2 years
Results posted on
2020-07-02
Participant Flow
Participant milestones
| Measure |
Single Vision Spectacle Lens
Single vision lens with power for correcting distance refraction.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
93
|
|
Overall Study
COMPLETED
|
81
|
79
|
|
Overall Study
NOT COMPLETED
|
9
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Myopia Control With the Multi-segment Lens
Baseline characteristics by cohort
| Measure |
Single Vision Spectacle Lens
n=90 Participants
Single vision lens with power for correcting distance refraction.
|
Multiple-Segment Spectacle Lens
n=93 Participants
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
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.01 years
STANDARD_DEVIATION 1.44 • n=5 Participants
|
10.19 years
STANDARD_DEVIATION 1.46 • n=7 Participants
|
10.09 years
STANDARD_DEVIATION 1.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
90 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
90 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
cycloplegic spherical equivalent refraction (SER)
|
-2.69 Diopters (D)
STANDARD_DEVIATION 0.98 • n=5 Participants
|
-2.92 Diopters (D)
STANDARD_DEVIATION 1.09 • n=7 Participants
|
-2.81 Diopters (D)
STANDARD_DEVIATION 1.01 • n=5 Participants
|
|
Axial length
|
24.62 mm
STANDARD_DEVIATION 0.82 • n=5 Participants
|
24.85 mm
STANDARD_DEVIATION 1.59 • n=7 Participants
|
24.74 mm
STANDARD_DEVIATION 1.27 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 yearsPopulation: completed 2-year study
Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.
Outcome measures
| Measure |
SV Group
n=81 Participants
single vision spectacle lens
|
MS Group
n=79 Participants
Multi-segment lens (or called DIMS lens)
|
|---|---|---|
|
Cycloplegic Refraction Change in SER
|
-0.93 Diopters (D)
Standard Deviation 0.58
|
-0.38 Diopters (D)
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: completed 2-year study
Axial length (mm) was measured after cycloplegia using IOL Master
Outcome measures
| Measure |
SV Group
n=81 Participants
single vision spectacle lens
|
MS Group
n=79 Participants
Multi-segment lens (or called DIMS lens)
|
|---|---|---|
|
Axial Length
|
0.53 mm
Standard Deviation 0.24
|
0.21 mm
Standard Deviation 0.22
|
Adverse Events
SV Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MS Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Carly Sin Yin Lam
School of Optometry, The Hong Kong Polytechnic University
Phone: 2766 6091
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place