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The purpose of this study is to compare 70 and 110 degree side-cut angles on the same patient undergoing Femtosecond Laser-assisted in Situ Keratomileusis (FS-LASIK).
LASIK has become the preferred corneal procedure to correct certain refractive errors. One of the major advancements in LASIK has been the introduction of Femtosecond Laser technology for flap creation. Several studies have compared microkeratome and femtosecond laser technology, showing superior accuracy and precision of flap dimensions in the latter.
The Femtosecond Laser technology provides different parameters and settings that can be changed according to the surgeon's preference. One of such parameters is the side-cut angle. Some of the most common side-cut angles used today include 45, 70, 90, and 110 degrees. Previous studies have reported on the visual outcomes of side-cut angles, but head to head comparisons are lacking. Currently, there are no studies comparing the safety and efficacy of the 70 and 110 side-cut angles in FS-LASIK. Information regarding the outcomes and complication rates between these side-cut angles will provide an objective measure that can be used when deciding which one is more suitable in FS-LASIK.
One angle will be performed on the right eye and the other on the left eye. The study will evaluate uncorrected visual acuity, best corrected visual acuity, intraoperative, and postoperative complications. Performing different side-cut angles on the same individual will allow a direct comparison of outcomes, minimizing confounding variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FS-LASIK 70 degree side-cut angle | Active Comparator | Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye. |
|
| FS-LASIK 110 degree side-cut angle | Active Comparator | Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FS-LASIK 70 degree side-cut angle | Device | FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Visual Acuity at One Year | Vision testing without correction, both eyes using Snellen Eye chart | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity at Year One | Vision testing with correction, both eyes using Snellen Eye chart | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark D Mifflin, MD | University of Utah Moran Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah John A. Moran Eye Center - Midvalley Location | Murray | Utah | 84107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FS-LASIK 70 Degree Side-cut Angle | Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye. FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. |
| FG001 | FS-LASIK 110 Degree Side-cut Angle | Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye. FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye. FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. |
| 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 | Uncorrected Visual Acuity at One Year | Vision testing without correction, both eyes using Snellen Eye chart | This is a contralateral eye study of 115 subjects, each with one eye randomized to the two study groups. | Posted | Mean | Standard Deviation | logMAR Visual Acuity | one year |
|
1 year
No risk for mortality from treatment
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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 | FS-LASIK 70 Degree Side-cut Angle | Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye. FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enhancement Needed | Surgical and medical procedures | Non-systematic Assessment | Eye needed an enhancement as uncorrected visual acuity was deemed unacceptable and needed to be improved with additional treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Nuttall | University of Utah | 8012133461 | elizabeth.nuttall@hsc.utah.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 | Jul 5, 2018 | Jan 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005128 | Eye Diseases |
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Each participant will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye
|
| FS-LASIK 110 degree side-cut angle | Device | FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. |
|
| Withdrawal by Subject |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | FS-LASIK 110 Degree Side-cut Angle | Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye. FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. |
|
|
| Secondary | Best Corrected Visual Acuity at Year One | Vision testing with correction, both eyes using Snellen Eye chart | Posted | Mean | Standard Deviation | logMAR Visual Acuity | one year |
|
|
|
| 0 |
| 115 |
| 0 |
| 115 |
| 2 |
| 115 |
| EG001 | FS-LASIK 110 Degree Side-cut Angle | Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye. FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol. | 0 | 115 | 0 | 115 | 2 | 115 |
|
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