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| Name | Class |
|---|---|
| Johnson & Johnson Vision Care, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bifocal Contact Lenses | Experimental | Use of bifocal contact lenses to control the progression of myopia |
|
| Control | Placebo Comparator | Single vision soft contact lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifocal Contact Lenses | Device | Use of bifocal contact lenses of varying add powers to control the progression of myopia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Cycloplegic Autorefraction in One Year. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Keratometric Changes at One Year. | One year | |
| Changes in Manifest Refraction at One Year. | One year | |
| Relationship Between Residual Fixation Disparity and Myopia Progression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas A. Aller, O.D. | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18601670 | Background | Aller TA, Wildsoet C. Bifocal soft contact lenses as a possible myopia control treatment: a case report involving identical twins. Clin Exp Optom. 2008 Jul;91(4):394-9. doi: 10.1111/j.1444-0938.2007.00230.x. | |
| 18201337 | Background | Tarrant J, Severson H, Wildsoet CF. Accommodation in emmetropic and myopic young adults wearing bifocal soft contact lenses. Ophthalmic Physiol Opt. 2008 Jan;28(1):62-72. doi: 10.1111/j.1475-1313.2007.00529.x. |
| Label | URL |
|---|---|
| Click here for more information about the CONTROL Study | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control | Single vision soft contact lenses Placebo Control: Single vision soft contact lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Numbers reflect those subjects screened, enrolled, randomized with at least one follow up examination.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Cycloplegic Autorefraction in One Year. | Posted | Mean | Standard Deviation | Diopters | One year |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Aller | Dr. Thomas Aller, Optometrist Inc. | 650 871-1816 | cptreyes@earthlink.net |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D004948 | Esotropia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D013285 | Strabismus |
| D015835 | Ocular Motility Disorders |
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| ID | Term |
|---|---|
| D003263 | Contact Lenses, Hydrophilic |
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Placebo Control | Device | Single vision soft contact lenses |
|
|
| One year |
| Changes in Cycloplegic Subjective Refraction in One Year | One year |
| Changes in Axial Length at One Year. | One year |
| Background | Aller TA. Design of a prospective clinical trial of the use of bifocal soft contact lenses to control myopia progression (CONTROL). Proceedings of the 10th International Myopia Conference 2004:29. |
| Result | Aller TA, Wildsoet C. Results of a one-year prospective clinical trial (CONTROL) of the use of bifocal soft contact lenses to control myopia progression. Ophthalmic and Physiological Optics 26(S1), 8-9. |
| 36809645 | Derived | Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2. |
Single vision soft contact lenses
Placebo Control: Single vision soft contact lenses
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Keratometric Changes at One Year. | Not Posted | One year |
| Secondary | Changes in Manifest Refraction at One Year. | Not Posted | One year |
| Secondary | Relationship Between Residual Fixation Disparity and Myopia Progression. | Not Posted | One year |
| Secondary | Changes in Cycloplegic Subjective Refraction in One Year | Not Posted | One year |
| Secondary | Changes in Axial Length at One Year. | Not Posted | One year |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Control | Single vision soft contact lenses Placebo Control: Single vision soft contact lenses | 0 | 40 | 0 | 40 |
The Investigator acknowledges that the data to be collected is proprietary. The Investigator agrees not to publish, divulge, reveal, disclose or otherwise make available, the data to others without the permission of sponsor unless the data have already been, or are subsequently published or disclosed by order of a court of law. The Investigator will not be free to publish papers dealing with the results of any Research performed under this Agreement without the consent of sponsor.
| D003389 |
| Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |