Myopia Control Using Optimized Optical Defocus RCTs

Myopia Clinical Trial

Official title:

Myopia Control Using Optimized Optical Defocus in Schoolchildren - a Randomized Double Masked Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03681366
• Other study ID #: HSEARS20180711001
• Status: Completed
• Phase: N/A
• Start date: October 25, 2018
• Est. completion date: June 24, 2022

Study information

• Verified date: August 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of the study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.

Description:

The purpose of the current study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses. The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas. The efficacy of the DISC3.5 Plus lens in slowing myopia progression (change in refractive error) will be compared to a spherical (front and back surface) single vision soft contact lenses in this one-year prospective, randomised and double-masked clinical trial. The hypothesis of this study is that the DISC3.5 Plus will slow myopia progression more than spherical single vision soft contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: June 24, 2022
• Est. primary completion date: May 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

Inclusion Criteria:

• Age at enrolment: 8-13 year; Hong Kong Chinese
• Spherical equivalent refractions (SER): -1.00 to -5.00D
• Astigmatism: -1.00D or less
• Anisometropia: 1.25D or less
• Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
• Contact lens corrected monocular VA: 0.1 logMAR or better
• Normal binocular function
• Willingness to wear contact lenses regularly
• Parents' understanding and acceptance of random allocation of grouping and masking

Exclusion Criteria:

• Prior myopia control treatment, e.g. orthokeratology, defocus soft contact lenses, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
• Strabismus or decompensated phoria (checked by cover test at far and near in screening)
• Known contraindications for contact lens wear
• Have any ocular and systemic diseases and abnormalities that might affect visual function or refractive development

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• DISC3.5 plus
The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.

Locations

Country	Name	City	State
China	The Centre of Myopia Ressearch, School of Optometry, The Hong Kong PolyU	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycloplegic Refraction Change in SER	Change in cycloplegic autorefraction in spherical equivalent (SER)	12 months
Secondary	Axial length	Axial length (mm) was measured after cycloplegia	12 months