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Myopia Control With the Multi-segment Lens

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ClinicalTrials.gov Identifier: NCT02206217
Recruitment Status : Completed
First Posted : August 1, 2014
Results First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
HOYA Corporation (Tokyo, Japan)
Information provided by (Responsible Party):
Carly Lam, The Hong Kong Polytechnic University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Myopia
Intervention Device: Multiple-Segment spectacle lens
Enrollment 183
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Vision Spectacle Lens Multiple-Segment Spectacle Lens
Hide 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
Arm/Group Title Single Vision Spectacle Lens Multiple-Segment Spectacle Lens Total
Hide 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 Number of Baseline Participants 90 93 183
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 93 participants 183 participants
10.01  (1.44) 10.19  (1.46) 10.09  (1.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 93 participants 183 participants
Female 40 38 78
Male 50 55 105
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 93 participants 183 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
90
 100.0%
93
 100.0%
183
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Hong Kong Number Analyzed 90 participants 93 participants 183 participants
90
 100.0%
93
 100.0%
183
 100.0%
cycloplegic spherical equivalent refraction (SER)  
Mean (Standard Deviation)
Unit of measure:  Diopters (D)
Number Analyzed 90 participants 93 participants 183 participants
-2.69  (0.98) -2.92  (1.09) -2.81  (1.01)
Axial length  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 90 participants 93 participants 183 participants
24.62  (0.82) 24.85  (1.59) 24.74  (1.27)
1.Primary Outcome
Title Cycloplegic Refraction Change in SER
Hide Description Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.
Time Frame Baseline and 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
completed 2-year study
Arm/Group Title SV Group MS Group
Hide Arm/Group Description:
single vision spectacle lens
Multi-segment lens (or called DIMS lens)
Overall Number of Participants Analyzed 81 79
Mean (Standard Deviation)
Unit of Measure: Diopters (D)
-0.93  (0.58) -0.38  (0.53)
2.Secondary Outcome
Title Axial Length
Hide Description Axial length (mm) was measured after cycloplegia using IOL Master
Time Frame Baseline and 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
completed 2-year study
Arm/Group Title SV Group MS Group
Hide Arm/Group Description:
single vision spectacle lens
Multi-segment lens (or called DIMS lens)
Overall Number of Participants Analyzed 81 79
Mean (Standard Deviation)
Unit of Measure: mm
0.53  (0.24) 0.21  (0.22)
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
Hide Arm/Group Description single vision spectacle lens Multi-segment lens (or called DIMS lens)
All-Cause Mortality
SV Group MS Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/90 (0.00%)   0/93 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
SV Group MS Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/90 (0.00%)   0/93 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SV Group MS Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/90 (0.00%)   0/93 (0.00%) 
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.
Results Point of Contact
Name/Title: Prof. Carly Sin Yin Lam
Organization: School of Optometry, The Hong Kong Polytechnic University
Phone: 2766 6091
Responsible Party: Carly Lam, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02206217     History of Changes
Other Study ID Numbers: H-ZG3B
First Submitted: July 29, 2014
First Posted: August 1, 2014
Results First Submitted: May 16, 2018
Results First Posted: July 31, 2019
Last Update Posted: July 31, 2019