Myopia Control Using Optimized Optical Defocus RCTs

NCT03681366 | Completed DMC

• 1 other identifier: HSEARS20180711001
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

myopia; Myopic Defocus; contact lens; myopia control

Outcome Measures

Primary Outcomes (1)

• Cycloplegic Refraction Change in SER

  Change in cycloplegic autorefraction in spherical equivalent (SER)

  12 months

Secondary Outcomes (1)

• Axial length

  12 months

Study Arms (2)

Single vision soft contact lens

NO INTERVENTION

single vision, spherical soft contact lens

DISC3.5 Plus lens

EXPERIMENTAL

A soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.

Device: DISC3.5 plus

Interventions

DISC3.5 plus DEVICE

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.

DISC3.5 Plus lens

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Centre of Myopia Ressearch, School of Optometry, The Hong Kong PolyU

Hong Kong, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Carly SY Lam, phD

  School of Optometry, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double masked design: The investigator(s) who were responsible for refracting and performing relevant ocular data measurement were masked from the grouping of the subjects. The unmasked investigator(s) were responsible for group allocation, spectacle-dispensing work, measuring lens visual performance, record keeping, data entry and compliance checking. Data input was carefully checked by the unmasked investigator and the other researchers independently. The children and their parents were also masked to group allocation until the data analysis was completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: October 25, 2018
• Primary Completion: May 8, 2021
• Study Completion: June 24, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-08

Locations

CN (1)