Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes

Sponsor
Gainesville Eye Associates (Other)
Overall Status
Completed
CT.gov ID
NCT04126174
Collaborator
Science in Vision (Other)
41
Enrollment
1
Location
2
Arms
17.1
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: femtosecond laser system arcuate corneal incision
  • Other: Manual LRI
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Contralateral eye studyContralateral eye study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes
Actual Study Start Date :
Oct 15, 2019
Actual Primary Completion Date :
Mar 20, 2021
Actual Study Completion Date :
Mar 20, 2021

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Femtosecond limbal relaxing incision (LRI)

Eyes will be treated with arcuate incisions from a femtosecond laser system.

Device: femtosecond laser system arcuate corneal incision
Corneal arcuate incision made either with a blade (manual) or femtosecond laser system.
Other Names:
  • LRI
  • Active Comparator: Manual LRI

    Eyes will be treated with arcuate incisions completed manually with a blade.

    Other: Manual LRI
    Manual LRI

    Outcome Measures

    Primary Outcome Measures

    1. Residual Refractive Astigmatism [3 months]

      Residual refractive astigmatism measured in diopters

    Secondary Outcome Measures

    1. Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D) [3 months]

      The number of eyes with residual refractive astigmatism < 0.50 diopters (D)

    2. Uncorrected Monocular Distance Visual Acuity [3 months]

      Uncorrected monocular distance visual acuity in logMAR

    3. Spherical Equivalent Refraction [3 months]

      Spherical equivalent refraction in diopters

    4. Corneal Astigmatism [3 months]

      Anterior corneal astigmatism

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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 exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

    • Irregular astigmatism (e.g. keratoconus)

    • 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Gainesville Eye AssociatesGainesvilleGeorgiaUnited States30501

    Sponsors and Collaborators

    • Gainesville Eye Associates
    • Science in Vision

    Investigators

    • Principal Investigator: Clayton G Blehm, MD, Gainesville Eye Associates

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Gainesville Eye Associates
    ClinicalTrials.gov Identifier:
    NCT04126174
    Other Study ID Numbers:
    • CB-19-001
    First Posted:
    Oct 15, 2019
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Gainesville Eye Associates
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleFemtosecond Limbal Relaxing Incision (LRI)Manual LRI
    Arm/Group DescriptionEyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
    Period Title: Overall Study
    STARTED4141
    COMPLETED3838
    NOT COMPLETED33

    Baseline Characteristics

    Arm/Group TitleAll Participants
    Arm/Group DescriptionCorneal arcuate incision made either with a blade (manual) or femtosecond laser system.
    Overall Participants38
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    69
    (7)
    Sex: Female, Male (Count of Participants)
    Female
    21
    55.3%
    Male
    17
    44.7%
    Race and Ethnicity Not Collected (Count of Participants)
    Region of Enrollment (Count of Participants)
    United States
    38
    100%

    Outcome Measures

    1. Primary Outcome
    TitleResidual Refractive Astigmatism
    DescriptionResidual refractive astigmatism measured in diopters
    Time Frame3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleFemtosecond Limbal Relaxing Incision (LRI)Manual LRI
    Arm/Group DescriptionEyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
    Measure Participants3838
    Measure Eyes3838
    Mean (Standard Deviation) [diopters]
    .21
    (.33)
    .22
    (.31)
    2. Secondary Outcome
    TitleEyes With Residual Refractive Astigmatism < 0.50 Diopters (D)
    DescriptionThe number of eyes with residual refractive astigmatism < 0.50 diopters (D)
    Time Frame3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleFemtosecond Limbal Relaxing Incision (LRI)Manual LRI
    Arm/Group DescriptionEyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
    Measure Participants3838
    Measure Eyes3838
    Count of Units [Eyes]
    36
    34
    3. Secondary Outcome
    TitleUncorrected Monocular Distance Visual Acuity
    DescriptionUncorrected monocular distance visual acuity in logMAR
    Time Frame3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleFemtosecond Limbal Relaxing Incision (LRI)Manual LRI
    Arm/Group DescriptionEyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
    Measure Participants3838
    Measure Eyes3838
    Mean (Standard Deviation) [logMAR]
    .1
    (.12)
    .08
    (.10)
    4. Secondary Outcome
    TitleSpherical Equivalent Refraction
    DescriptionSpherical equivalent refraction in diopters
    Time Frame3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleFemtosecond Limbal Relaxing Incision (LRI)Manual LRI
    Arm/Group DescriptionEyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
    Measure Participants3838
    Measure Eyes3838
    Mean (Standard Deviation) [diopters]
    -.02
    (.37)
    0
    (.27)
    5. Secondary Outcome
    TitleCorneal Astigmatism
    DescriptionAnterior corneal astigmatism
    Time Frame3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleFemtosecond Limbal Relaxing Incision (LRI)Manual LRI
    Arm/Group DescriptionEyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
    Measure Participants3838
    Measure Eyes3838
    Mean (Standard Deviation) [diopters]
    .63
    (.34)
    .7
    (.4)

    Adverse Events

    Time Frame3 months
    Adverse Event Reporting Description
    Arm/Group TitleFemtosecond Limbal Relaxing Incision (LRI)Manual LRI
    Arm/Group DescriptionEyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
    All Cause Mortality
    Femtosecond Limbal Relaxing Incision (LRI)Manual LRI
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/41 (0%) 0/41 (0%)
    Serious Adverse Events
    Femtosecond Limbal Relaxing Incision (LRI)Manual LRI
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/41 (0%) 0/41 (0%)
    Other (Not Including Serious) Adverse Events
    Femtosecond Limbal Relaxing Incision (LRI)Manual LRI
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/41 (0%) 2/41 (4.9%)
    Eye disorders
    Full thickness perforation0/41 (0%) 02/41 (4.9%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleClayton Blehm, MD
    OrganizationGainesville Eye Associates
    Phone7705324444
    Emailclaytonblehm@gmail.com
    Responsible Party:
    Gainesville Eye Associates
    ClinicalTrials.gov Identifier:
    NCT04126174
    Other Study ID Numbers:
    • CB-19-001
    First Posted:
    Oct 15, 2019
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Feb 1, 2021