Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions

• Sponsor: Gainesville Eye Associates (Other)
• Overall Status: Completed
• CT.gov ID: NCT02763124
• Collaborator: Alcon, a Novartis Company (Industry)
• Enrollment: 18
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

To assess the effectiveness of the Verion-LenSx guided arcuate incision technique to reduce astigmatism in a pseudophakic population.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Procedure: Verion-LenSx	N/A

Detailed Description

The purpose of this study is to evaluate the effectiveness of corneal arcuate incisions when they are performed with a femtosecond laser system on subjects who have had previous cataract surgery. The procedure to be used would not be different from that employed during cataract surgery, except that the only corneal incisions made would be the partial-depth arcuate incisions at the laser.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Verion-LenSx The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions.	Procedure: Verion-LenSx; The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions

Outcome Measures

Primary Outcome Measures

1. Uncorrected Monocular Distance Visual Acuity [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.

Secondary Outcome Measures

1. Change in Corneal Astigmatism [60 days (+/- 10 days) after laser treatment]

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

2. Change in Refractive Cylinder [60 days (+/- 10 days) after laser treatment]

   The vector change in refractive cylinder in diopters

3. Spectacle Independence at Distance [60 days (+/- 10 days) after laser treatment]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 40 or older

• Willing and able to provide informed consent for participation in the study.

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gainesville Eye Associates	Gainesville	Georgia	United States	30501

Sponsors and Collaborators

• Gainesville Eye Associates
• Alcon, a Novartis Company

Investigators

• Principal Investigator: Clayton Blehm, MD, Gainesville Eye Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clayton Blehm, MD, PI, Gainesville Eye Associates
• ClinicalTrials.gov Identifier: NCT02763124
• Other Study ID Numbers: CB-16-001
• First Posted: May 5, 2016
• Last Update Posted: Nov 1, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Clayton Blehm, MD, PI, Gainesville Eye Associates: Pseudophakic
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Arm/Group Title	Verion-LenSx
Arm/Group Description	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
Period Title: Overall Study
STARTED	18
COMPLETED	18
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Verion-LenSx
Arm/Group Description	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 Participants	18
Overall Eyes	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.8 (6.1)
Sex: Female, Male (Eyes) [Count of Units]
Female	19
Male	9
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	18 100%
Refractive cylinder (diopters) (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	1.35 (0.30)
Average keratometry (diopters) (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	44.27 (1.41)
Corneal astigmatism (diopters) (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	1.42 (.54)

Outcome Measures

1. Primary Outcome

Title	Uncorrected Monocular Distance Visual Acuity
Description	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.
Time Frame	60 days (+/- 10 days) after laser treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Verion-LenSx
Arm/Group Description	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
Measure Participants	18
Measure Eyes	28
Mean (Standard Deviation) [logMAR]	0.14 (0.11)

2. Secondary Outcome

Title	Change in Corneal Astigmatism
Description	Vector change in the astigmatism measured on the cornea, in diopters
Time Frame	60 days (+/- 10 days) after laser treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Verion-LenSx
Arm/Group Description	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
Measure Participants	18
Measure Eyes	28
Mean (Standard Deviation) [diopters]	1.2 (0.74)

3. Secondary Outcome

Title	Change in Refractive Cylinder
Description	The vector change in refractive cylinder in diopters
Time Frame	60 days (+/- 10 days) after laser treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Verion-LenSx
Arm/Group Description	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
Measure Participants	18
Measure Eyes	28
Mean (Standard Deviation) [diopters]	1.21 (0.42)

4. Secondary Outcome

Title	Spectacle Independence at Distance
Description	Percentage of subjects that do not rely on spectacles for distance vision
Time Frame	60 days (+/- 10 days) after laser treatment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Verion-LenSx
Arm/Group Description	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
Measure Participants	18
Count of Participants [Participants]	12 66.7%

Adverse Events

Time Frame	Two months
Arm/Group Title	Verion-LenSx
Arm/Group Description	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
All Cause Mortality
	Verion-LenSx
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Serious Adverse Events
	Verion-LenSx
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Other (Not Including Serious) Adverse Events
	Verion-LenSx
	Affected / at Risk (%)	# Events
Total	1/18 (5.6%)
Eye disorders
Corneal ulcer	1/18 (5.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.