Esophoria, Fixation Disparity, Myopia
Conditions
Keywords
Myopia Progression, Myopia Control, Bifocal Contact Lenses, Esophoria, Fixation Disparity
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBifocal Contact Lenses
Use of bifocal contact lenses of varying add powers to control the progression of myopia
DEVICEPlacebo Control
Single vision soft contact lenses
Sponsors
Johnson & Johnson Vision Care, Inc.
Aller, Thomas A., OD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
Yes
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
Exclusion criteria
* Presence of ocular disease preventing wear of contacts * Pregnancy or nursing * Use of certain medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Cycloplegic Autorefraction in One Year. | One year |
Secondary
| Measure | Time frame |
|---|---|
| Relationship Between Residual Fixation Disparity and Myopia Progression. | One year |
| Changes in Cycloplegic Subjective Refraction in One Year | One year |
| Changes in Axial Length at One Year. | One year |
| Keratometric Changes at One Year. | One year |
| Changes in Manifest Refraction at One Year. | One year |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bifocal Contact Lenses Use of bifocal contact lenses to control the progression of myopia
Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia | 38 |
| Control Single vision soft contact lenses
Placebo Control: Single vision soft contact lenses | 40 |
| Total | 78 |
Baseline characteristics
| Characteristic | Bifocal Contact Lenses | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 38 Participants | 40 Participants | 78 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 27 Participants | 27 Participants | 54 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 40 |
| serious Total, serious adverse events | 0 / 38 | 0 / 40 |
Outcome results
Primary
Changes in Cycloplegic Autorefraction in One Year.
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bifocal Contact Lenses | Changes in Cycloplegic Autorefraction in One Year. | -0.22 Diopters | Standard Deviation 0.34 |
| Control | Changes in Cycloplegic Autorefraction in One Year. | -0.78 Diopters | Standard Deviation 0.45 |
Secondary
Changes in Axial Length at One Year.
Time frame: One year
Secondary
Changes in Cycloplegic Subjective Refraction in One Year
Time frame: One year
Secondary
Changes in Manifest Refraction at One Year.
Time frame: One year
Secondary
Keratometric Changes at One Year.
Time frame: One year
Secondary
Relationship Between Residual Fixation Disparity and Myopia Progression.
Time frame: One year