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This study will evaluate changes in refractive error and visual performance between a single vision soft contact lens and multifocal soft contact lens
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single vision soft contact lens first, then multifocal soft contact lens | Experimental | Participants wore the single vision soft contact lens first, then a multifocal soft contact lens |
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| Multifocal soft contact lens first, then single vision soft contact lens | Experimental | Participants wore the multifocal soft contact lens first, then the single vision soft contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single vision contact lens | Device | Participants will wear a single vision soft contact lens during the study visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Performance | Low contrast visual acuity was measured for each participant while wearing each of the two lenses | Through completion of study visit, an average of 2.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Spherical Equivalent Refractive Error On-axis | Refraction was measured after cycloplegia with two drops of 1% tropicamide hydrochloride. Spherical equivalent refractive error was then measured 3 times with an aberrometer and averaged. | Through completion of study visit, an average of 2.5 hours |
| Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Berntsen, OD, PhD | University of Houston College of Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Houston | Houston | Texas | 77204 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Vision Soft Contact Lens First, Then Multifocal Soft Contact Lens | Participants wore the single vision soft contact lens first, then the multifocal soft contact lens |
| FG001 | Multifocal Soft Contact Lens First, Then Single Vision Soft Contact Lens | Participants wore the multifocal soft contact lens first, then the single vision soft contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (40 Mins) |
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| Washout (5 Mins) |
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| Second Intervention (40 Mins) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Vision Soft Contact Lens First, Then Multifocal Soft Contact Lens | Participants wore the single vision soft contact lens first, then the multifocal soft contact lens |
| BG001 | Multifocal Soft Contact Lens First, Then Single Vision Soft Contact Lens |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Visual Performance | Low contrast visual acuity was measured for each participant while wearing each of the two lenses | Posted | Mean | Standard Deviation | logMAR | Through completion of study visit, an average of 2.5 hours |
|
2.5 hours
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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 | Single Vision Contact Lens | Participants wore a single vision contact lens | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David A Berntsen, OD PhD | University of Houston | 713-743-5836 | dberntsen@uh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2020 | Jan 12, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 16, 2020 | Jan 12, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Participants were masked to the order in which they wore contact lenses
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| Multifocal contact lens | Device | Participants will wear a multifocal soft contact lens during the study visit |
|
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Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged. |
| Through completion of study visit, an average of 2.5 hours |
| Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina | Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged. | Through completion of study visit, an average of 2.5 hours |
| Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina | Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged. | Through completion of study visit, an average of 2.5 hours |
| Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina | Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged. | Through completion of study visit, an average of 2.5 hours |
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| NOT COMPLETED |
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Participants wore the multifocal soft contact lens first, then the single vision soft contact lens |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
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| Secondary | Spherical Equivalent Refractive Error On-axis | Refraction was measured after cycloplegia with two drops of 1% tropicamide hydrochloride. Spherical equivalent refractive error was then measured 3 times with an aberrometer and averaged. | Posted | Mean | Standard Deviation | D | Through completion of study visit, an average of 2.5 hours |
|
|
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| Secondary | Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina | Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged. | Posted | Mean | Standard Deviation | D | Through completion of study visit, an average of 2.5 hours |
|
|
|
| Secondary | Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina | Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged. | Posted | Mean | Standard Deviation | D | Through completion of study visit, an average of 2.5 hours |
|
|
|
| Secondary | Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina | Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged. | Posted | Mean | Standard Deviation | D | Through completion of study visit, an average of 2.5 hours |
|
|
|
| Secondary | Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina | Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged. | Posted | Mean | Standard Deviation | D | Through completion of study visit, an average of 2.5 hours |
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|
|
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Multifocal Contact Lens | Participants wore a multifocal contact lens | 0 | 7 | 0 | 7 | 0 | 7 |
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