NCT02763124

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

November 1, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

May 3, 2016

Results QC Date

February 20, 2019

Last Update Submit

October 11, 2019

Conditions

Astigmatism

Keywords

Pseudophakic

Outcome Measures

Primary Outcomes (1)

  • Uncorrected Monocular Distance Visual Acuity

    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.

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

Secondary Outcomes (3)

  • Change in Corneal Astigmatism

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

  • Change in Refractive Cylinder

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

  • Spectacle Independence at Distance

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

Study Arms (1)

Verion-LenSx

EXPERIMENTAL

The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions.

Procedure: Verion-LenSx

Interventions

Verion-LenSxPROCEDURE

The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions

Verion-LenSx

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 or older
  • Willing and able to provide informed consent for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gainesville Eye Associates

Gainesville, Georgia, 30501, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Clayton Blehm, MD
Organization
Gainesville Eye Associates
claytonblehm@gmail.com
7705324444

Study Officials

  • Clayton Blehm, MD

    Gainesville Eye Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 5, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 1, 2019

Results First Posted

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)