Trial Outcomes & Findings for Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes (NCT NCT04126174)

NCT ID: NCT04126174

Last Updated: 2021-09-05

Results Overview

Residual refractive astigmatism measured in diopters

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-09-05

Participant Flow

Unit of analysis: Eye

Participant milestones

Measure	Femtosecond Limbal Relaxing Incision (LRI) Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Manual LRI Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Overall Study STARTED	41 41	41 41
Overall Study COMPLETED	38 38	38 38
Overall Study NOT COMPLETED	3 3	3 3

Reasons for withdrawal

Measure	Femtosecond Limbal Relaxing Incision (LRI) Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Manual LRI Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

Only subjects completing the study were included in the baseline analysis.

Baseline characteristics by cohort

Measure	All Participants n=38 Participants Corneal arcuate incision made either with a blade (manual) or femtosecond laser system.
Age, Continuous	69 years STANDARD_DEVIATION 7 • n=38 Participants • Only subjects completing the study were included in the baseline analysis.
Sex: Female, Male Female	21 Participants n=38 Participants • Only subjects completing the study were included in the baseline analysis.
Sex: Female, Male Male	17 Participants n=38 Participants • Only subjects completing the study were included in the baseline analysis.
Region of Enrollment United States	38 Participants n=38 Participants • Only subjects completing the study were included in the analysis population.

PRIMARY outcome

Timeframe: 3 months

Residual refractive astigmatism measured in diopters

Outcome measures

Measure	Femtosecond Limbal Relaxing Incision (LRI) n=38 Eyes Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Manual LRI n=38 Eyes Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Residual Refractive Astigmatism	.21 diopters Standard Deviation .33	.22 diopters Standard Deviation .31

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	Femtosecond Limbal Relaxing Incision (LRI) n=38 Eyes Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Manual LRI n=38 Eyes Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D)	36 Eyes	34 Eyes

SECONDARY outcome

Timeframe: 3 months

Uncorrected monocular distance visual acuity in logMAR

Outcome measures

Measure	Femtosecond Limbal Relaxing Incision (LRI) n=38 Eyes Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Manual LRI n=38 Eyes Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Uncorrected Monocular Distance Visual Acuity	.1 logMAR Standard Deviation .12	.08 logMAR Standard Deviation .10

SECONDARY outcome

Timeframe: 3 months

Spherical equivalent refraction in diopters

Outcome measures

Measure	Femtosecond Limbal Relaxing Incision (LRI) n=38 Eyes Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Manual LRI n=38 Eyes Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Spherical Equivalent Refraction	-.02 diopters Standard Deviation .37	0 diopters Standard Deviation .27

SECONDARY outcome

Timeframe: 3 months

Anterior corneal astigmatism

Outcome measures

Measure	Femtosecond Limbal Relaxing Incision (LRI) n=38 Eyes Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Manual LRI n=38 Eyes Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Corneal Astigmatism	.63 diopters Standard Deviation .34	.7 diopters Standard Deviation .4

Adverse Events

Femtosecond Limbal Relaxing Incision (LRI)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Manual LRI

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Femtosecond Limbal Relaxing Incision (LRI) n=41 participants at risk Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Manual LRI n=41 participants at risk Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Eye disorders Full thickness perforation	0.00% 0/41 • 3 months	4.9% 2/41 • Number of events 2 • 3 months

Additional Information

Clayton Blehm, MD

Gainesville Eye Associates

Phone: 7705324444

Email: claytonblehm@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place