Myopia Control Using Optimized Optical Defocus RCTs

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: DISC3.5 plus

• Registration Number: NCT03681366
• Lead Sponsor: The Hong Kong Polytechnic University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-24
• Study Start: 2018-10-25
• Primary Completion: 2021-05-08
• Study Completion: 2022-06-24
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DISC3.5 Plus lens	DISC3.5 plus	A soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.

Primary Outcome Measures

Name	Time	Method
Cycloplegic Refraction Change in SER	12 months	Change in cycloplegic autorefraction in spherical equivalent (SER)

Secondary Outcome Measures

Name	Time	Method
Axial length	12 months	Axial length (mm) was measured after cycloplegia

Trial Locations

Locations (1)

The Centre of Myopia Ressearch, School of Optometry, The Hong Kong PolyU; 🇨🇳 Hong Kong, China