Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes
NCT ID: NCT04126174
Last Updated: 2021-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2019-10-15
2021-03-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Femtosecond limbal relaxing incision (LRI)
Eyes will be treated with arcuate incisions from a femtosecond laser system.
femtosecond laser system arcuate corneal incision
Corneal arcuate incision made either with a blade (manual) or femtosecond laser system.
Manual LRI
Eyes will be treated with arcuate incisions completed manually with a blade.
Manual LRI
Manual LRI
Interventions
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femtosecond laser system arcuate corneal incision
Corneal arcuate incision made either with a blade (manual) or femtosecond laser system.
Manual LRI
Manual LRI
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* Corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye)
* Monocular status (e.g. amblyopia)
* Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty)
* Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
* Diabetic retinopathy
* Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)
* History of retinal detachment
* Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect post-operative visual acuity.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
40 Years
ALL
Yes
Sponsors
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Science in Vision
OTHER
Gainesville Eye Associates
OTHER
Responsible Party
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Principal Investigators
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Clayton G Blehm, MD
Role: PRINCIPAL_INVESTIGATOR
Gainesville Eye Associates
Locations
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Gainesville Eye Associates
Gainesville, Georgia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CB-19-001
Identifier Type: -
Identifier Source: org_study_id
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