NCT04126174

Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes

Completed NA Results posted Last updated 5 September 2021

What this trial tests

NA trial testing femtosecond laser system arcuate corneal incision in Cataract in 41 participants. Completed in 20 March 2021.

Timeline

15 October 2019

Primary endpoint
20 March 2021

20 March 2021

Quick facts

Lead sponsor	Gainesville Eye Associates
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	15 October 2019
Primary completion	20 March 2021
Estimated completion	20 March 2021
Sites	1 location across United States

Drugs / interventions tested

• femtosecond laser system arcuate corneal incision
• Manual LRI

Conditions studied

• Cataract — all drugs for Cataract →

Sponsor

Gainesville Eye Associates

Who can join

40 and older, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Residual Refractive Astigmatism Primary · 3 months

Residual refractive astigmatism measured in diopters

Group	Value	95% CI
Femtosecond Limbal Relaxing Incision (LRI)	.21	± .33
Manual LRI	.22	± .31

Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D) Secondary · 3 months

The number of eyes with residual refractive astigmatism \< 0.50 diopters (D)

Group	Value	95% CI
Femtosecond Limbal Relaxing Incision (LRI)	36
Manual LRI	34

Uncorrected Monocular Distance Visual Acuity Secondary · 3 months

Uncorrected monocular distance visual acuity in logMAR

Group	Value	95% CI
Femtosecond Limbal Relaxing Incision (LRI)	.1	± .12
Manual LRI	.08	± .10

Spherical Equivalent Refraction Secondary · 3 months

Spherical equivalent refraction in diopters

Group	Value	95% CI
Femtosecond Limbal Relaxing Incision (LRI)	-.02	± .37
Manual LRI	0	± .27

Corneal Astigmatism Secondary · 3 months

Anterior corneal astigmatism

Group	Value	95% CI
Femtosecond Limbal Relaxing Incision (LRI)	.63	± .34
Manual LRI	.7	± .4

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Femtosecond Limbal Relaxing Incision (LRI)

Serious: 0/41 (0%)

Deaths: 0/41

Manual LRI

Serious: 0/41 (0%)

Deaths: 0/41

Other adverse events (1 terms — click to expand)

Reaction	System	Femtosecond Limbal Relaxin…	Manual LRI
Full thickness perforation	Eye disorders	—	—

Data from ClinicalTrials.gov NCT04126174 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Outcomes After Femtosecond Laser-Assisted Arcuate Corneal Incisions versus Manual Incisions.
   Blehm C, Potvin R. · · 2021 · cited 3× · PMID 34194220 · DOI 10.2147/opth.s321358