Myopia Control With Simultaneous Vision Approach

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression in Hong Kong schoolchildren using simultaneous vision approach.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Myopia Control Using Optimized Optical Defocus RCTs

NCT03681366

Myopia

COMPLETED NA

The Effect of Blue-light Filtering Spectacle Lenses on Myopia Progression in Schoolchildren

NCT03538002

Myopia

COMPLETED NA

Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children

NCT01236742

Myopia

COMPLETED NA

Retardation of Myopia in Orthokeratology

NCT00962208

Myopia

COMPLETED NA

Peripheral Optics in Myopia and Orthokeratology

NCT00978679

Myopia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators hypothesize that the natural process of emmetropization in human is regulated by the equilibrium between the opposite hyperopic and myopic defocus. A sharp focus of retinal image (foveal fixation) is fundamental for co-ordination of the equilibrium. The DISC lens is a custom-made multi-zone bifocal soft contact lens which is based on simultaneously provides clear vision and defocus at all viewing distances. It comprises of correcting zones for correcting distant prescription(correction of refractive error, and defocusing zones to incorporate constant myopic defocus for slowing down myopia progression.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

single vision soft contact lens

Single vision soft contact lenses with same materials of the DISC lens

Group Type NO_INTERVENTION

No interventions assigned to this group

Defocus Incorporated Soft Contact (DISC) lens

The use of DISC lens to slow down the progression of myopia

Group Type EXPERIMENTAL

Defocus Incorporated Soft Contact (DISC) lens

Intervention Type DEVICE

Use of simultaneous vision bifocal soft contact lenses with myopic defocus to control the progression of myopia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Defocus Incorporated Soft Contact (DISC) lens

Use of simultaneous vision bifocal soft contact lenses with myopic defocus to control the progression of myopia

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

myopia control myopia progression Simultaneous vision bifocal contact lens

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 8-13 years
* Myopia (SE) between -1D to -5D
* Astigmatism less than or equal to -1D
* Anisometropia: less than or equal to 1.25D
* aided VA (monocular): 0.00 log MAR or better
* willingness to wear contact lens constantly
* availability for follow-up for at least 2.5 years
* parents' understanding and acceptance
* willing to provide refractive status of grandparents

Exclusion Criteria

* Severe ocular or systemic allergies
* Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
* Ocular or systemic condition that might affect refractive development
* Strabismus at distance or near
* Prior use of bifocal or progressive lenses
* Prior use of rigid gas permeable lenses and Ortho-K lenses

Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes