Cataract
Conditions
Keywords
astigmatism, limbal relaxing incisions
Brief summary
This study is designed to compare the effectiveness of LenSx laser arcuate relaxing incisions vs. manual (blade) arcuate relaxing incisions in patients with low, but significant, levels of astigmatism.
Detailed description
This study is a comparative, prospective, randomized contralateral eye study of visual outcomes after LenSx laser arcuate relaxing incisions utilizing the Woodcock nomogram at 90% thickness vs. manual (blade) fixed keratome diamond knife at 600 microns for arcuate relaxing incisions utilizing the Donnenfeld nomogram. Subjects will be assessed pre-operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction and corneal astigmatism measurement with the Lenstar and slit lamp exam.
Interventions
DEVICEfemtosecond laser system arcuate corneal incision
Corneal arcuate incision made either with a blade (manual) or femtosecond laser system.
OTHERManual LRI
Manual LRI
Sponsors
Science in Vision
Gainesville Eye Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Contralateral eye study
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. * are willing and able to understand and sign an informed consent; * are willing and able to attend all study visits; * are more than 40 years of age, of either gender and any race; * are presenting for cataract surgery or refractive lens exchange with a desire to reduce astigmatism and will be implanted with a non-toric lens * have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) * have 0.50 D to 1.75 D of regular corneal astigmatism * have potential acuity of 20/25 or better * Are scheduled to have a non-toric monofocal intraocular lens (IOL) (SN60WF) lens implanted in both eyes
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual Refractive Astigmatism | 3 months | Residual refractive astigmatism measured in diopters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D) | 3 months | The number of eyes with residual refractive astigmatism \< 0.50 diopters (D) |
| Uncorrected Monocular Distance Visual Acuity | 3 months | Uncorrected monocular distance visual acuity in logMAR |
| Spherical Equivalent Refraction | 3 months | Spherical equivalent refraction in diopters |
| Corneal Astigmatism | 3 months | Anterior corneal astigmatism |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Corneal arcuate incision made either with a blade (manual) or femtosecond laser system. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 38 Participants | — |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 |
| other Total, other adverse events | 0 / 41 | 2 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 |
Outcome results
Primary
Residual Refractive Astigmatism
Residual refractive astigmatism measured in diopters
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femtosecond Limbal Relaxing Incision (LRI) | Residual Refractive Astigmatism | .21 diopters | Standard Deviation 0.33 |
| Manual LRI | Residual Refractive Astigmatism | .22 diopters | Standard Deviation 0.31 |
Secondary
Corneal Astigmatism
Anterior corneal astigmatism
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femtosecond Limbal Relaxing Incision (LRI) | Corneal Astigmatism | .63 diopters | Standard Deviation 0.34 |
| Manual LRI | Corneal Astigmatism | .7 diopters | Standard Deviation 0.4 |
Secondary
Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D)
The number of eyes with residual refractive astigmatism \< 0.50 diopters (D)
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Femtosecond Limbal Relaxing Incision (LRI) | Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D) | 36 Eyes |
| Manual LRI | Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D) | 34 Eyes |
Secondary
Spherical Equivalent Refraction
Spherical equivalent refraction in diopters
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femtosecond Limbal Relaxing Incision (LRI) | Spherical Equivalent Refraction | -.02 diopters | Standard Deviation 0.37 |
| Manual LRI | Spherical Equivalent Refraction | 0 diopters | Standard Deviation 0.27 |
Secondary
Uncorrected Monocular Distance Visual Acuity
Uncorrected monocular distance visual acuity in logMAR
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femtosecond Limbal Relaxing Incision (LRI) | Uncorrected Monocular Distance Visual Acuity | .1 logMAR | Standard Deviation 0.12 |
| Manual LRI | Uncorrected Monocular Distance Visual Acuity | .08 logMAR | Standard Deviation 0.1 |