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| Name | Class |
|---|---|
| Alcon, a Novartis Company | INDUSTRY |
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To assess the effectiveness of the Verion-LenSx guided arcuate incision technique to reduce astigmatism in a pseudophakic population.
The purpose of this study is to evaluate the effectiveness of corneal arcuate incisions when they are performed with a femtosecond laser system on subjects who have had previous cataract surgery. The procedure to be used would not be different from that employed during cataract surgery, except that the only corneal incisions made would be the partial-depth arcuate incisions at the laser.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verion-LenSx | Experimental | The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verion-LenSx | Procedure | The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Monocular Distance Visual Acuity | Uncorrected monocular distance visual acuity, measured on a logMAR scale, (logarithm of the Minimum Angle of Resolution) which is a measure of visual acuity in which the smaller values indicate better visual acuity. | 60 days (+/- 10 days) after laser treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Corneal Astigmatism | Vector change in the astigmatism measured on the cornea, in diopters | 60 days (+/- 10 days) after laser treatment |
| Change in Refractive Cylinder | The vector change in refractive cylinder in diopters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clayton Blehm, MD | Gainesville Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gainesville Eye Associates | Gainesville | Georgia | 30501 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Verion-LenSx | The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions. Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Verion-LenSx | The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions. Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Uncorrected Monocular Distance Visual Acuity | Uncorrected monocular distance visual acuity, measured on a logMAR scale, (logarithm of the Minimum Angle of Resolution) which is a measure of visual acuity in which the smaller values indicate better visual acuity. | Posted | Mean | Standard Deviation | logMAR | 60 days (+/- 10 days) after laser treatment | Eyes | Eyes |
|
|
Two months
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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 | Verion-LenSx | The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions. Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal ulcer | Eye disorders | Non-systematic Assessment | Corneal ulcer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clayton Blehm, MD | Gainesville Eye Associates | 7705324444 | claytonblehm@gmail.com |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| 60 days (+/- 10 days) after laser treatment |
| Spectacle Independence at Distance | Percentage of subjects that do not rely on spectacles for distance vision | 60 days (+/- 10 days) after laser treatment |
| Eyes |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Units | Eyes | Eyes |
|
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
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| Refractive cylinder (diopters) | Mean | Standard Deviation | diopters | Eyes |
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| Average keratometry (diopters) | Mean | Standard Deviation | diopters | Eyes |
|
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| Corneal astigmatism (diopters) | Mean | Standard Deviation | diopters | Eyes |
|
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| Participants |
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| Eyes |
|
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| Secondary | Change in Corneal Astigmatism | Vector change in the astigmatism measured on the cornea, in diopters | Posted | Mean | Standard Deviation | diopters | 60 days (+/- 10 days) after laser treatment | Eyes | Eyes |
|
|
|
| Secondary | Change in Refractive Cylinder | The vector change in refractive cylinder in diopters | Posted | Mean | Standard Deviation | diopters | 60 days (+/- 10 days) after laser treatment | Eyes | Eyes |
|
|
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| Secondary | Spectacle Independence at Distance | Percentage of subjects that do not rely on spectacles for distance vision | There were 28 eyes of 18 subjects treated in the study. Spectacle independence is evaluated by subject, not eye. | Posted | Count of Participants | Participants | 60 days (+/- 10 days) after laser treatment |
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|
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| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
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