Trial Outcomes & Findings for Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions (NCT NCT02763124)

NCT ID: NCT02763124

Last Updated: 2019-11-01

Results Overview

Uncorrected monocular distance visual acuity, measured on a logMAR scale, (logarithm of the Minimum Angle of Resolution) which is a measure of visual acuity in which the smaller values indicate better visual acuity.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: 60 days (+/- 10 days) after laser treatment
• Results posted on: 2019-11-01

Participant Flow

Unit of analysis: Eyes

Participant milestones

Measure	Verion-LenSx The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions. Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions
Overall Study STARTED	18 28
Overall Study COMPLETED	18 28
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions

Baseline characteristics by cohort

Measure	Verion-LenSx n=28 Eyes The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions. Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions
Age, Continuous	68.8 years STANDARD_DEVIATION 6.1 • n=18 Participants
Sex: Female, Male Female	19 Eyes n=28 Eyes
Sex: Female, Male Male	9 Eyes n=28 Eyes
Region of Enrollment United States	18 participants n=18 Participants
Refractive cylinder (diopters)	1.35 diopters STANDARD_DEVIATION 0.30 • n=28 Eyes
Average keratometry (diopters)	44.27 diopters STANDARD_DEVIATION 1.41 • n=28 Eyes
Corneal astigmatism (diopters)	1.42 diopters STANDARD_DEVIATION .54 • n=28 Eyes

PRIMARY outcome

Timeframe: 60 days (+/- 10 days) after laser treatment

Uncorrected monocular distance visual acuity, measured on a logMAR scale, (logarithm of the Minimum Angle of Resolution) which is a measure of visual acuity in which the smaller values indicate better visual acuity.

Outcome measures

Measure	Verion-LenSx n=28 Eyes The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions. Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions
Uncorrected Monocular Distance Visual Acuity	0.14 logMAR Standard Deviation 0.11

SECONDARY outcome

Timeframe: 60 days (+/- 10 days) after laser treatment

Vector change in the astigmatism measured on the cornea, in diopters

Outcome measures

Measure	Verion-LenSx n=28 Eyes The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions. Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions
Change in Corneal Astigmatism	1.2 diopters Standard Deviation 0.74

SECONDARY outcome

Timeframe: 60 days (+/- 10 days) after laser treatment

The vector change in refractive cylinder in diopters

Outcome measures

Measure	Verion-LenSx n=28 Eyes The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions. Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions
Change in Refractive Cylinder	1.21 diopters Standard Deviation 0.42

SECONDARY outcome

Timeframe: 60 days (+/- 10 days) after laser treatment

Population: There were 28 eyes of 18 subjects treated in the study. Spectacle independence is evaluated by subject, not eye.

Percentage of subjects that do not rely on spectacles for distance vision

Outcome measures

Measure	Verion-LenSx n=18 Participants The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions. Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions
Spectacle Independence at Distance	12 Participants

Adverse Events

Verion-LenSx

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Verion-LenSx n=18 participants at risk The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions. Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions
Eye disorders Corneal ulcer	5.6% 1/18 • Number of events 1 • Two 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