NCT03122535

Brief Summary

The purpose of this study is to compare 70 and 110 degree side-cut angles on the same patient undergoing Femtosecond Laser-assisted in Situ Keratomileusis (FS-LASIK).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 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

October 7, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2019

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

May 28, 2021

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

4.5 years

First QC Date

February 18, 2017

Results QC Date

January 4, 2021

Last Update Submit

May 4, 2021

Conditions

Operative Incision

Keywords

Femtosecond LASIK (FS--LASIK)Visual acuityRefractive errorsSide-cut angles

Outcome Measures

Primary Outcomes (1)

  • Uncorrected Visual Acuity at One Year

    Vision testing without correction, both eyes using Snellen Eye chart

    one year

Secondary Outcomes (1)

  • Best Corrected Visual Acuity at Year One

    one year

Study Arms (2)

FS-LASIK 70 degree side-cut angle

ACTIVE COMPARATOR

Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.

Device: FS-LASIK 70 degree side-cut angleDevice: FS-LASIK 110 degree side-cut angle

FS-LASIK 110 degree side-cut angle

ACTIVE COMPARATOR

Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.

Device: FS-LASIK 70 degree side-cut angleDevice: FS-LASIK 110 degree side-cut angle

Interventions

FS-LASIK 70 degree side-cut angleDEVICE

FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.

FS-LASIK 110 degree side-cut angleFS-LASIK 70 degree side-cut angle
FS-LASIK 110 degree side-cut angleDEVICE

FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.

FS-LASIK 110 degree side-cut angleFS-LASIK 70 degree side-cut angle

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are deemed suitable candidates for bilateral LASIK will be considered eligible for participation in this study. Correction will be distance for both eyes.

You may not qualify if:

  • Selection will be consistent with current standard of care. Any patient that is not a suitable candidate for LASIK will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah John A. Moran Eye Center - Midvalley Location

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

Surgical WoundRefractive Errors

Condition Hierarchy (Ancestors)

Wounds and InjuriesEye Diseases

Results Point of Contact

Title
Elizabeth Nuttall
Organization
University of Utah
elizabeth.nuttall@hsc.utah.edu
8012133461

Study Officials

  • Mark D Mifflin, MD

    University of Utah Moran Eye Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Each participant will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Ophthalmology/Visual Sciences

Study Record Dates

First Submitted

February 18, 2017

First Posted

April 20, 2017

Study Start

October 7, 2014

Primary Completion

March 21, 2019

Study Completion

March 21, 2019

Last Updated

May 28, 2021

Results First Posted

May 28, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)