Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes

Cataract Clinical Trial

Official title:

Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04126174
• Other study ID #: CB-19-001
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: March 20, 2021

Study information

• Verified date: February 2021
• Source: Gainesville Eye Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 20, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Surgical Wound

Intervention

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

Other:
• Manual LRI
Manual LRI

Locations

Country	Name	City	State
United States	Gainesville Eye Associates	Gainesville	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Gainesville Eye Associates	Science in Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual Refractive Astigmatism	Residual refractive astigmatism measured in diopters	3 months
Secondary	Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D)	The number of eyes with residual refractive astigmatism < 0.50 diopters (D)	3 months
Secondary	Uncorrected Monocular Distance Visual Acuity	Uncorrected monocular distance visual acuity in logMAR	3 months
Secondary	Spherical Equivalent Refraction	Spherical equivalent refraction in diopters	3 months
Secondary	Corneal Astigmatism	Anterior corneal astigmatism	3 months