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| ID | Type | Description | Link |
|---|---|---|---|
| U10EY023208 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Houston | OTHER |
| National Eye Institute (NEI) | NIH |
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This study will evaluate the use of two different bifocal contact lens add powers to prevent further nearsighted progression in children ages 7 to 11 years old. It is theorized that the profile of the bifocal lenses will decrease the amount of change in nearsightedness that the children experience.
The primary goal of this project is to determine whether a commercially available soft bifocal contact lens with a distance-center design can slow myopia progression in children. Using soft bifocal contact lenses to manipulate the peripheral optics of the eye is a novel use for a standard contact lens that may keep children from becoming as nearsighted as they would otherwise. Secondary goals are to determine whether the amount of myopic defocus imposed on the peripheral retina by soft bifocal contact lenses is associated in a dose-dependent manner with slowed myopic progression and to determine whether peripheral myopic blur acts to slow eye growth locally or globally. These important pieces of information will enable investigators to learn about the role of peripheral optics for regulating eye growth, which could ultimately lead to optimization of optical signals to slow myopia progression. Ultimately, the information could be used to design optical devices to prevent the onset of myopia in young children.
Slowing myopia progression or eventually preventing myopia onset could potentially affect approximately 60 million children in the United States alone. While the consequences of myopia are rarely sight-threatening, the quality of life for myopic patients is negatively affected and the health care costs to treat myopia are astronomical (approximately $4.6 billion in 1990). The National Eye Institute recognizes the need to "evaluate the efficacy of potential treatments for delaying the onset or for slowing the progression of myopia, such as lenses that alter peripheral defocus."
Using a common treatment of myopia (contact lenses) to potentially slow myopia progression and to learn about optical signals that regulate eye growth is a very novel approach to solving a problem that affects a large proportion of people in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofinity | Active Comparator | Soft spherical contact lens |
|
| Biofinity Multifocal D +1.50 add | Experimental | The Biofinity Multifocal "D" with a +1.50 add is a soft bifocal contact lens that has a medium reading power |
|
| Biofinity Multifocal D +2.50 add | Experimental | The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofinity Multifocal D +1.50 add | Device | This is a monthly disposable contact lens commercially available from CooperVision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Refractive Error Progression | Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Shape Change and Eye Growth | The outcome of interest is the change in ocular shape and measured by the change in peripheral refractive error in the right eye. The change in peripheral refractive error will be compared among the two treatment groups and the control group to determine whether peripheral defocus changes the shape of the eye globally (across the whole eye) or locally (specific to the region of the eye affected by the defocus). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Walline, OD, PhD | Ohio State University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University College of Optometry | Columbus | Ohio | 43210 | United States | ||
| University of Houston College of Optometry |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37369096 | Derived | Chandler MA, Robich ML, Jordan LA, Mutti DO, Berntsen DA, Fenton R, Day E, Walline JJ; BLINK2 Study Group. Accommodation in Children after 4.7 Years of Multifocal Contact Lens Wear in the BLINK Study Randomized Clinical Trial. Optom Vis Sci. 2023 Jul 1;100(7):425-431. doi: 10.1097/OPX.0000000000002040. Epub 2023 Jun 24. | |
| 35413027 | Derived | Gaume Giannoni A, Robich M, Berntsen DA, Jones-Jordan LA, Mutti DO, Myers J, Shaw K, Walker MK, Walline JJ; BLINK Study Group. Ocular and Nonocular Adverse Events during 3 Years of Soft Contact Lens Wear in Children. Optom Vis Sci. 2022 Jun 1;99(6):505-512. doi: 10.1097/OPX.0000000000001902. Epub 2022 Apr 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biofinity | Soft spherical contact lens Biofinity: This is a monthly disposable spherical contact lens commercially available from CooperVision |
| FG001 | Biofinity Multifocal D +1.50 Add | The Biofinity Multifocal "D" with a +1.50 add is a soft bifocal contact lens that has a medium reading power Biofinity Multifocal D +1.50 add: This is a monthly disposable contact lens commercially available from CooperVision |
| FG002 | Biofinity Multifocal D +2.50 Add | The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power Biofinity Multifocal D +2.50 add: This is a monthly disposable contact lens commercially available from CooperVision |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biofinity | Single vision soft contact lens |
| BG001 | Biofinity +1.50 D Add | Medium add soft bifocal contact lens (+1.50 Diopter add) |
| 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 | Refractive Error Progression | Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses). | Posted | Mean | Standard Deviation | Diopters | 3 years |
|
Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
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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 | Biofinity | Spherical soft contact lens | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SEAL | Eye disorders | Systematic Assessment | Superior Epithelial Arcuate Lesion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Walline | The Ohio State University | 614-247-6840 | walline.1@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: University of Houston Informed Consent | Aug 1, 2014 | Aug 19, 2019 | ICF_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2018 | Jun 24, 2020 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Ohio State University Clinical Site | Nov 5, 2015 | Aug 11, 2020 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Biofinity Multifocal D +2.50 add | Device | This is a monthly disposable contact lens commercially available from CooperVision |
|
| Biofinity | Device | This is a monthly disposable spherical contact lens commercially available from CooperVision |
|
| 3 years |
| Association of Peripheral Defocus to Myopic Progression | Peripheral defocus will be measured in 10 areas (Nasal and temporal zones at 20, 30, and 40 degrees, and superior and inferior zones at 20 and 30 degrees) and analyzed for its relation to myopia progression (as measured by cycloplegic autorefraction in the right eye only). | 3 years |
| Axial Length Progression | Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses). | 3 years |
| Houston |
| Texas |
| 77204 |
| United States |
| 32780139 | Derived | Walline JJ, Walker MK, Mutti DO, Jones-Jordan LA, Sinnott LT, Giannoni AG, Bickle KM, Schulle KL, Nixon A, Pierce GE, Berntsen DA; BLINK Study Group. Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial. JAMA. 2020 Aug 11;324(6):571-580. doi: 10.1001/jama.2020.10834. |
| 29561497 | Derived | Schulle KL, Berntsen DA, Sinnott LT, Bickle KM, Gostovic AT, Pierce GE, Jones-Jordan LA, Mutti DO, Walline JJ; Bifocal Lenses in Nearsighted Kids (BLINK) Study Group. Visual Acuity and Over-refraction in Myopic Children Fitted with Soft Multifocal Contact Lenses. Optom Vis Sci. 2018 Apr;95(4):292-298. doi: 10.1097/OPX.0000000000001207. |
| 28737608 | Derived | Walline JJ, Gaume Giannoni A, Sinnott LT, Chandler MA, Huang J, Mutti DO, Jones-Jordan LA, Berntsen DA; BLINK Study Group. A Randomized Trial of Soft Multifocal Contact Lenses for Myopia Control: Baseline Data and Methods. Optom Vis Sci. 2017 Sep;94(9):856-866. doi: 10.1097/OPX.0000000000001106. |
| BG002 | Biofinity +2.50 D Add | High add soft bifocal contact lens (+2.50 Diopter add) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Site | Count of Participants | Participants |
|
| Spherical equivalent | Diopters | Mean | Standard Deviation | Diopters |
|
| Axial length | mm | Mean | Standard Deviation | mm |
|
| Peripheral axial length | Mean | Standard Deviation | mm |
|
| Peripheral defocus | Mean | Standard Deviation | Diopters |
|
High add soft bifocal contact lens (+2.50 Diopter add) |
|
|
|
| Secondary | Ocular Shape Change and Eye Growth | The outcome of interest is the change in ocular shape and measured by the change in peripheral refractive error in the right eye. The change in peripheral refractive error will be compared among the two treatment groups and the control group to determine whether peripheral defocus changes the shape of the eye globally (across the whole eye) or locally (specific to the region of the eye affected by the defocus). | Analysis of peripheral eye length changes with treatment | Posted | Mean | Standard Deviation | mm | 3 years |
|
|
|
|
| Secondary | Association of Peripheral Defocus to Myopic Progression | Peripheral defocus will be measured in 10 areas (Nasal and temporal zones at 20, 30, and 40 degrees, and superior and inferior zones at 20 and 30 degrees) and analyzed for its relation to myopia progression (as measured by cycloplegic autorefraction in the right eye only). | outcome is three-year change in refractive error as a function of baseline peripheral defocus | Posted | Mean | Standard Deviation | Diopters | 3 years |
|
|
|
|
| Secondary | Axial Length Progression | Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses). | Posted | Mean | Standard Deviation | mm | 3 years |
|
|
|
|
| 98 |
| 0 |
| 98 |
| 72 |
| 97 |
| EG001 | Biofinity +1.50 D Add | Medium add soft bifocal contact lens (+1.50 Diopter add) | 0 | 98 | 0 | 98 | 71 | 98 |
| EG002 | Biofinity +2.50 D Add | High add soft bifocal contact lens (+2.50 Diopter add) | 0 | 98 | 0 | 98 | 75 | 97 |
| CLARE | Eye disorders | Systematic Assessment | Contact lens associated red eye |
|
| Corneal epithelial defect | Eye disorders | Systematic Assessment |
|
| Infiltrative keratitis | Eye disorders | Systematic Assessment |
|
| Probable microbial keratitis | Eye disorders | Systematic Assessment |
|
| Sterile Corneal Ulcer | Eye disorders | Systematic Assessment |
|
| Toxic exposure | Eye disorders | Systematic Assessment | gas. soap in eye |
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| Giant papillary conjunctivitis | Eye disorders | Systematic Assessment |
|
| Ocular allergies | Eye disorders | Systematic Assessment |
|
| Blepharitis | Eye disorders | Systematic Assessment |
|
| Hordeolum/chalazion | Eye disorders | Systematic Assessment |
|
| Eyelash issue | Eye disorders | Systematic Assessment |
|
| Ptosis | Eye disorders | Systematic Assessment |
|
| Corneal scar, new | Eye disorders | Systematic Assessment |
|
| Solution induced corneal staining | Eye disorders | Systematic Assessment |
|
| Poor contact lens fit | Eye disorders | Systematic Assessment |
|
| Foreign body | Eye disorders | Systematic Assessment |
|
| Dry eye | Eye disorders | Systematic Assessment |
|
| Contact lens solution issue | Eye disorders | Systematic Assessment |
|
| Conjunctivitis, any type | Eye disorders | Systematic Assessment |
|
| Subconjunctival hemorrhage | Eye disorders | Systematic Assessment |
|
| Retinal issue | Eye disorders | Systematic Assessment |
|
| Optic nerve issue | Eye disorders | Systematic Assessment |
|
| Uveitis | Eye disorders | Systematic Assessment |
|
| Trauma, ocular | Eye disorders | Systematic Assessment |
|
| Binocular vision/accommodation issue | Eye disorders | Systematic Assessment |
|
| Color vision defect | Eye disorders | Systematic Assessment |
|
| Transient visual disturbance | Eye disorders | Systematic Assessment |
|
| Unspecified contact lens issue | Eye disorders | Systematic Assessment |
|
| Visual symptoms, no obvious cause | Eye disorders | Systematic Assessment |
|
| Allergy, non-ocular | Immune system disorders | Systematic Assessment |
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| Trauma, non-ocular | General disorders | Systematic Assessment |
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| Headaches | General disorders | Systematic Assessment |
|
| Concussion | General disorders | Systematic Assessment |
|
| Systemic disease | General disorders | Systematic Assessment |
|
| Mental health issues | Psychiatric disorders | Systematic Assessment |
|
| Can't categorize | General disorders | Systematic Assessment |
|
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|
| 20 degree superior |
|
| 20 degree temporal |
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| 30 degree inferior |
|
| 30 degree nasal |
|
| 30 degree superior |
|
| 30 degree temporal |
|