Bifocal Soft Contact Lenses and Their Effect on Myopia Progression in Children and Adolescents.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

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

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-03-31

Brief Summary

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

The purpose of this study is to determine whether bifocal soft contact lenses are effective in controlling the progression of myopia in children and adolescents that exhibit a tendency to excessively cross their eyes while reading (esophoria or eso fixation disparity). Several studies have demonstrated that bifocal or progressive multifocal spectacles are effective in slowing the progression of myopia in children either with near point esophoria and/or with inadequate focusing at near. A prominent theory for one cause of myopia progression is that poorly focused images on the back of the eye (retina) cause the eye to lengthen, causing an increase in myopia. Bifocal contact lenses may reduce this retinal defocus, reducing the stimulus to eye elongation, and thus may reduce myopia progression.

Related Clinical Trials

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

A Trial of Bifocals in Myopic Children With Esophoria

NCT00000128

Myopia Strabismus Esophoria

UNKNOWN PHASE3

Bifocal Lenses In Nearsighted Kids

NCT02255474

Refractive Errors

COMPLETED NA

Myopia Control Using Soft Bifocal Lenses

NCT02643758

Myopia

TERMINATED NA

Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control

NCT04080128

Myopia

COMPLETED NA

Contact Lenses and Myopia

NCT02180347

Myopia

COMPLETED

Detailed Description

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

Myopia has become the focus of growing attention and concern because the prevalence of myopia appears to increasing in some populations (reaching 90% for some university student populations in Asia). There are serious risks to higher levels of myopia, including cataracts, glaucoma, retinal detachment and myopic retinal degeneration. Several studies have shown mild to moderate control of myopia progressionwith bifocal or multifocal spectacles in children with esophoria at near and/or with accommodative deficiencies. Pilot studies by the P.I. have suggested that bifocal contact lenses may control myopia progression in children with near point eso fixation disparity.

CONTROL is a controlled, randomized, prospective, double-blind, one year study of the changes in myopia in 80-90 subjects from age 8-18 with low to moderate levels of myopia, low levels of astigmatism, and eso fixation disparity at near, when fitted with either bifocal soft contact lenses or single vision soft contact lenses. The primary outcome measures will be cycloplegic refraction and axial length measures.

Conditions

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

Myopia Esophoria Fixation Disparity

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

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Bifocal Contact Lenses

Use of bifocal contact lenses to control the progression of myopia

Group Type EXPERIMENTAL

Bifocal Contact Lenses

Intervention Type DEVICE

Use of bifocal contact lenses of varying add powers to control the progression of myopia

Control

Single vision soft contact lenses

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type DEVICE

Single vision soft contact lenses

Interventions

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

Bifocal Contact Lenses

Use of bifocal contact lenses of varying add powers to control the progression of myopia

Intervention Type DEVICE

Placebo Control

Single vision soft contact lenses

Intervention Type DEVICE

Other Intervention Names

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

Bifocal Soft Contact Lenses Hydrophilic Bifocal Contact Lenses Simultaneous Vision Bifocal Contact Lenses Soft Contact Lenses Hydrophilic Contact Lenses Single Vision Soft Contact Lenses

Eligibility Criteria

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

Inclusion Criteria

* Myopia between -0.50 and -6.00
* Eso fixation disparity at 33cm with distance correction
* Astigmatism 1.00 or less
* Ability to wear soft contact lenses