Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes

NCT04126174 | Completed Results FDA Device

• 1 other identifier: CB-19-001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

astigmatism, limbal relaxing incisions

Outcome Measures

Primary Outcomes (1)

• Residual Refractive Astigmatism

  Residual refractive astigmatism measured in diopters

  3 months

Secondary Outcomes (4)

• Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D)

  3 months

• Uncorrected Monocular Distance Visual Acuity

  3 months

• Spherical Equivalent Refraction

  3 months

• Corneal Astigmatism

  3 months

Study Arms (2)

Femtosecond limbal relaxing incision (LRI)

ACTIVE COMPARATOR

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

Device: femtosecond laser system arcuate corneal incision

Manual LRI

ACTIVE COMPARATOR

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

Other: Manual LRI

Interventions

femtosecond laser system arcuate corneal incision DEVICE

Corneal arcuate incision made either with a blade (manual) or femtosecond laser system.

Also known as: LRI

Femtosecond limbal relaxing incision (LRI)

Manual LRI OTHER

Manual LRI

Manual LRI

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gainesville Eye Associates: lead
• Science in Vision: collaborator

Study Sites (1)

Gainesville Eye Associates

Gainesville, Georgia, 30501, United States

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Results Point of Contact

• Title: Clayton Blehm, MD
• Organization: Gainesville Eye Associates

claytonblehm@gmail.com

7705324444

Study Officials

• Clayton G Blehm, MD

  Gainesville Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Contralateral eye study

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: October 15, 2019
• Primary Completion: March 20, 2021
• Study Completion: March 20, 2021
• Last Updated: September 5, 2021
• Results First Posted: September 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)