Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myopia Progression Trial With Novel Myopia Control Design Spectacle Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04048148
Recruitment Status : Active, not recruiting
First Posted : August 7, 2019
Last Update Posted : January 28, 2021
Sponsor:
Collaborators:
Essilor International
Hai Yen Eye Care
Information provided by (Responsible Party):
Rebecca Weng, Brien Holden Vision Institute

Tracking Information
First Submitted Date  ICMJE August 4, 2019
First Posted Date  ICMJE August 7, 2019
Last Update Posted Date January 28, 2021
Actual Study Start Date  ICMJE May 31, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2021)
Cycloplegic refraction [ Time Frame: Up to 18 months ]
Change in myopia progression measured by cycloplegic refraction (Diopters) using Shin Nippon Auto-refractor
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
Cycloplegic refraction [ Time Frame: Up to 12 months ]
Change in myopia progression measured by cycloplegic refraction (Diopters) using Shin Nippon Auto-refractor
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2021)
Axial length [ Time Frame: Up to 18 months ]
Change in ocular axial length (mm) measured using Lenstar Optical Biometer
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
Axial length [ Time Frame: Up to 12 months ]
Change in ocular axial length (mm) measured using Lenstar Optical Biometer
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myopia Progression Trial With Novel Myopia Control Design Spectacle Lenses
Official Title  ICMJE A Double-masked, Randomized, Cross-over Comparative Study of Novel Myopia Control Designed Lens (Test Lens) Versus Single Vision Lens (SVL; Control)
Brief Summary This is a mono-center, randomized, double-masked, cross-over study to evaluate rate of myopia progression with novel designed myopia control lens (test) compared to SVL (control). A total of 120 children will be recruited where 60 participants each will be randomized either to wear test (Group 1) or SVL lenses (Group 2) for 6 months each. At the end of the 6 months period, there will be a cross- over of lenses and the lenses evaluated for a further 6 months. At the end of the 12 month period, all participants (Group 1 and Group 2) will wear test lenses for another 6 months.
Detailed Description

Myopia has been considered as a 'global epidemic' owing to its rapid rise in prevalence across the world. Myopia significantly affects the quality of life of an individual socially by restriction of employment in various fields and economically by additional cost for eye care and spectacles and contact lenses (Lim, Gazzard et al. 2009). In addition, high myopia increases the risk of ocular morbidity such as retinal detachment, cataract, glaucoma which can could lead to blindness. Several optical and pharmaceutical strategies were developed over the recent years that could control or slow the progression of myopia.

It has been shown that persistent myopic defocus constantly applied on the whole retina has a beneficial effect on myopia progression, i.e. decrease in myopia progression (Anstice and Phillips 2011, Cheng, Woo et al. 2011, Ehsaei, Chisholm et al. 2011). In addition, a meta-analysis on the efficacy of non-invasive optical treatment strategies for myopia control reported prismatic bifocals to have the best outcome (Cheng, Woo et al. 2011). Therefore, test lenses were designed to increase the area and amount of myopic defocus on the retina without compromising vision.

Thus, this study aims to evaluate the efficacy of test lenses to reduce the progression of myopia by either reducing the myopia progression rate per year and/or reducing the elongation of eyeball through myopic defocus compared with SVL. A total of 120 healthy children aged 8 to 13 years will be recruited to participate in a double-masked cross-over clinical trial. Cycloplegic autorefraction will be the primary measure for myopia progression and axial length will the secondary outcome measure. Visual acuity will also be compared between test lens and control lens to determine the quality of vision using test lens.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
This is a mono-center, randomized, double-masked, cross-over study to evaluate if novel design lens can slow down the progression of myopia. A total of 120 healthy children aged between 8 years to 13 years with myopia (-0.75D to -4.75D) meeting the inclusion and exclusion criteria will be recruited. These children will be randomized to wear test lenses followed by control lenses (Group 1) or to wear control lenses followed by test lenses (Group 2). At the end of the 12 month period, all participants will wear test lenses for another 6 months. All children will be followed at 3-monthly intervals for 1.5 years to monitor for changes in axial length and 6-monthly for changes in cycloplegic autorefraction. The cross-over design allows to compare treatment effects between the two groups at 6 months, 12 months and at 18 months. In addition, at the end of the study, the treatment effects can be compared within subject as each subject will have worn both lenses and serves as his/her control.
Masking: Double (Participant, Investigator)
Masking Description:
Participants and their parents / guardians and investigators will be masked to their lens assignment. Test spectacles will be of similar appearance to control spectacles and will not be easily identified without specialized equipment. Test and control spectacles will be assigned a code (A or B) by the clinical coordinator and stored in a secure location.
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE Device: Novel designed myopia control spectacle lenses
A novel designed myopia control spectacle lenses (test lenses) will be given to both arms to wear for 12 months.
Study Arms  ICMJE
  • Novel myopia control lenses
    This group will be randomized to wear test lenses for 6 months followed by control lenses for 6 months and then test lenses for another 6 months
    Intervention: Device: Novel designed myopia control spectacle lenses
  • Single vision lenses
    This group will be randomized to wear control lenses for 6 months followed by test lenses for 12 months
    Intervention: Device: Novel designed myopia control spectacle lenses
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 26, 2021)
132
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2019)
120
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

General inclusion criterion:

- Volunteer subject and guardian, fluent Vietnamese spoken, willing to follow the protocol and able to read, comprehend and sign the informed consent form.

Study related inclusion criteria:

  • Age: equal to or greater than 8 years and not older than 13 years.
  • Spherical refractive error of -0.75 to -4.75 D in each eye (spherical equivalent), as measured by cycloplegic autorefraction.
  • Astigmatism of not more than 1.50 D.
  • Anisometropia of not more than 1.00 D.
  • Best corrected visual acuity of equal or better than 0.05 LogMAR
  • No strabismus by cover test at near and distance.
  • Have the ability to comply with the protocol to get the reliable study measurements.
  • Absence of ocular disease with full ophthalmic examination, such as retinal disease, cataract and ptosis. Good general health, without systemic or neurodevelopmental conditions. Without ocular or systemic medicine, which might affect myopia progression or visual acuity through known effects on retina, accommodation or significant elevation of intraocular pressure.
  • No history of progressive addition lenses (PALs) or bifocal use and no prior use of contact lenses

Exclusion Criteria:

General exclusion criteria:

  • Vulnerability of the subject,
  • Participation in another study which might have an influence on vision or interfere with study assessments.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04048148
Other Study ID Numbers  ICMJE VCRTC2019-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Clinical study report will be shared once the study is completed. Study anticipate to be completed in 2020.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: The data will become available mid 2021, starting 6 months after publication.
Current Responsible Party Rebecca Weng, Brien Holden Vision Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Brien Holden Vision Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Essilor International
  • Hai Yen Eye Care
Investigators  ICMJE
Study Director: Padmaja Sankaridurg, PhD Brien Holden Vision Institute
PRS Account Brien Holden Vision Institute
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP