Clinical trial NCT04126174: Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes
Official title: Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: astigmatism, limbal relaxing incisions
Lead sponsor: Gainesville Eye Associates
Sponsor class: OTHER
Collaborators: name: Science in Vision
First posted: 2019-10-15
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Contralateral eye study
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Residual Refractive Astigmatism
timeFrame: 3 months
Secondary outcomes:
measure: Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D)
timeFrame: 3 months
measure: Uncorrected Monocular Distance Visual Acuity
timeFrame: 3 months
measure: Spherical Equivalent Refraction
timeFrame: 3 months
measure: Corneal Astigmatism
timeFrame: 3 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Gainesville Eye Associates
state: Georgia
Study officials:
affiliation: Gainesville Eye Associates
name: Clayton G Blehm, MD
role: PRINCIPAL_INVESTIGATOR
References: