N/A
N=82
Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT04126174 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Residual Refractive Astigmatism — .21; .22 diopters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- femtosecond laser system arcuate corneal incision (Device); Manual LRI (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Gainesville Eye Associates
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Refractive Astigmatism |
.21; .22 | — |
| SECONDARY Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D) |
36; 34 | — |
| SECONDARY Uncorrected Monocular Distance Visual Acuity |
.1; .08 | — |
| SECONDARY Spherical Equivalent Refraction |
-.02; 0 | — |
| SECONDARY Corneal Astigmatism |
.63; .7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04126174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.