Operative IncisionNCT03122535
70 vs 110 Degree Side-cut Angles in Femtosecond LASIK
A study testing FS-LASIK 70 degree side-cut angle and FS-LASIK 110 degree side-cut angle in people with Operative Incision, run by University of Utah at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Operative Incision
- What is being tested?
- FS-LASIK 70 degree side-cut angle and FS-LASIK 110 degree side-cut angle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2014to 21 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are deemed suitable candidates for bilateral LASIK will be considered eligible for participation in this study. Correction will be distance for both eyes.
Who cannot join
- Selection will be consistent with current standard of care. Any patient that is not a suitable candidate for LASIK will not be included.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah John A. Moran Eye Center - Midvalley Location
Murray, Utah, 84107
About this study
Official title: 70 Versus 110 Degrees Side-cut Angles in Femtosecond Laser-assisted in Situ Keratomileusis
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).
Read the detailed description
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.
- Conditions
- Operative Incision
- Being tested
- FS-LASIK 70 degree side-cut angle, FS-LASIK 110 degree side-cut angle
- Keywords
- Femtosecond LASIK (FS--LASIK), Visual acuity, Refractive errors, Side-cut angles
- Medical subject headings
- Surgical Wound, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FS-LASIK 70 degree side-cut angleDevice
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 angleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FS-LASIK 70 degree side-cut angle; Device: FS-LASIK 110 degree side-cut angle |
| 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. Receives: Device: FS-LASIK 70 degree side-cut angle; Device: FS-LASIK 110 degree side-cut angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Visual Acuity at One Year
Vision testing without correction, both eyes using Snellen Eye chart
Measured: one year
Secondary outcomes (1)
Best Corrected Visual Acuity at Year One
Vision testing with correction, both eyes using Snellen Eye chart
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start7 Oct 2014
- Primary completion21 Mar 2019
- Study completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Operative IncisionStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Mifflin, University of Utah
- Investigators
- Mark D Mifflin, MD, Principal investigator, University of Utah Moran Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122535
- Sponsor's protocol ID
- IRB 74858
- Status last verified
- May 2021
- First submitted
- 18 Feb 2017
- Last updated
- 28 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 70 Versus 110 Degrees Side-cut Angles in Femtosecond Laser-assisted in Situ Keratomileusis
- ClinicalTrials.gov ID
- NCT03122535
- Acronym / sponsor ID
- IRB 74858
- Conditions
- Operative Incision
- Keywords
- Femtosecond LASIK (FS--LASIK), Visual acuity, Refractive errors, Side-cut angles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 7 Oct 2014 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Posted 28 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FS-LASIK 70 degree side-cut angle | Active comparator | Device: FS-LASIK 70 degree side-cut angle, Device: FS-LASIK 110 degree side-cut angleEach 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 | Device: FS-LASIK 70 degree side-cut angle, Device: FS-LASIK 110 degree side-cut angleEach 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who are deemed suitable candidates for bilateral LASIK will be considered eligible for participation in this study. Correction will be distance for both eyes.
Key exclusion criteria (1 listed)
- Selection will be consistent with current standard of care. Any patient that is not a suitable candidate for LASIK will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FS-LASIK 70 degree side-cut angleFS-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. | Device | FS-LASIK 110 degree side-cut angle, FS-LASIK 70 degree side-cut angle |
| FS-LASIK 110 degree side-cut angleFS-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. | Device | FS-LASIK 110 degree side-cut angle, FS-LASIK 70 degree side-cut angle |
Primary outcome
Uncorrected Visual Acuity at One Year
Time frame: one year
Vision testing without correction, both eyes using Snellen Eye chart
1 secondary outcome
Best Corrected Visual Acuity at Year One
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Operative Incision
Not yet recruiting
The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery
Ventral Hernia, Ventral Incisional Hernia
Recruiting
ENVELOP: Wound Care Following Pilonidal Sinus Surgery
Pilonidal Sinus, Wound Healing
Enrolling by invitationPhase 4
Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee
Prosthetic-joint Infection, Dysbiosis
Enrolling by invitation
Comparing the Impact of AMNIOEFFECT Application vs Standard of Care on Post-Operative Healing in Patients Who Have Undergone Thyroid and Parathyroid Surgery Via the Transcutaneous Approach
Thyroid; Wound, Parathyroid Diseases
Active, not recruiting
PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds
Wound Surgical, Wound Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D Mifflin, MD principal investigator
University of Utah Moran Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FS-LASIK 70 degree side-cut angle and FS-LASIK 110 degree side-cut angle in people with Operative Incision, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Visual Acuity at One Year (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.