Astigmatism
Conditions
Keywords
Pseudophakic
Brief summary
To assess the effectiveness of the Verion-LenSx guided arcuate incision technique to reduce astigmatism in a pseudophakic population.
Detailed description
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.
Interventions
PROCEDUREVerion-LenSx
The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions
Sponsors
Alcon, a Novartis Company
Gainesville Eye Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 40 or older * Willing and able to provide informed consent for participation in the study.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Monocular Distance Visual Acuity | 60 days (+/- 10 days) after laser treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Corneal Astigmatism | 60 days (+/- 10 days) after laser treatment | Vector change in the astigmatism measured on the cornea, in diopters |
| Change in Refractive Cylinder | 60 days (+/- 10 days) after laser treatment | The vector change in refractive cylinder in diopters |
| Spectacle Independence at Distance | 60 days (+/- 10 days) after laser treatment | Percentage of subjects that do not rely on spectacles for distance vision |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| 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 | 28 |
| Total | 46 |
Baseline characteristics
| Characteristic | Verion-LenSx |
|---|---|
| Age, Continuous | 68.8 years STANDARD_DEVIATION 6.1 |
| Average keratometry (diopters) | 44.27 diopters STANDARD_DEVIATION 1.41 |
| Corneal astigmatism (diopters) | 1.42 diopters STANDARD_DEVIATION 0.54 |
| Refractive cylinder (diopters) | 1.35 diopters STANDARD_DEVIATION 0.3 |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 19 Eyes |
| Sex: Female, Male Male | 9 Eyes |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 1 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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.
Time frame: 60 days (+/- 10 days) after laser treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Verion-LenSx | Uncorrected Monocular Distance Visual Acuity | 0.14 logMAR | Standard Deviation 0.11 |
Secondary
Change in Corneal Astigmatism
Vector change in the astigmatism measured on the cornea, in diopters
Time frame: 60 days (+/- 10 days) after laser treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Verion-LenSx | Change in Corneal Astigmatism | 1.2 diopters | Standard Deviation 0.74 |
Secondary
Change in Refractive Cylinder
The vector change in refractive cylinder in diopters
Time frame: 60 days (+/- 10 days) after laser treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Verion-LenSx | Change in Refractive Cylinder | 1.21 diopters | Standard Deviation 0.42 |
Secondary
Spectacle Independence at Distance
Percentage of subjects that do not rely on spectacles for distance vision
Time frame: 60 days (+/- 10 days) after laser treatment
Population: There were 28 eyes of 18 subjects treated in the study. Spectacle independence is evaluated by subject, not eye.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Verion-LenSx | Spectacle Independence at Distance | 12 Participants |