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Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04126174
Recruitment Status : Enrolling by invitation
First Posted : October 15, 2019
Last Update Posted : December 12, 2019
Sponsor:
Collaborator:
Science in Vision
Information provided by (Responsible Party):
Gainesville Eye Associates

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 disease Intervention/treatment Phase
Cataract Device: femtosecond laser system arcuate corneal incision Other: Manual LRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Contralateral 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 : October 15, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/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 Name: LRI

Active Comparator: Manual LRI
Eyes will be treated with arcuate incisions completed manually with a blade.
Other: Manual LRI
Manual LRI




Primary Outcome Measures :
  1. Residual refractive astigmatism [ Time Frame: 3 months ]
    Residual refractive astigmatism


Secondary Outcome Measures :
  1. Percentage of eyes with residual refractive astigmatism < 0.50 diopters (D) [ Time Frame: 3 months ]
    Percentage of eyes with residual refractive astigmatism < 0.50 diopters (D)

  2. Uncorrected monocular distance visual acuity [ Time Frame: 3 months ]
    Uncorrected monocular distance visual acuity

  3. Spherical equivalent refraction [ Time Frame: 3 months ]
    Spherical equivalent refraction

  4. Corneal astigmatism [ Time Frame: 3 months ]
    Corneal astigmatism



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126174


Locations
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United States, Georgia
Gainesville Eye Associates
Gainesville, Georgia, United States, 30501
Sponsors and Collaborators
Gainesville Eye Associates
Science in Vision
Investigators
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Principal Investigator: Clayton G Blehm, MD Gainesville Eye Associates

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Responsible Party: Gainesville Eye Associates
ClinicalTrials.gov Identifier: NCT04126174    
Other Study ID Numbers: CB-19-001
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
astigmatism, limbal relaxing incisions
Additional relevant MeSH terms:
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Cataract
Surgical Wound
Lens Diseases
Eye Diseases
Wounds and Injuries