NCT02575911

Brief Summary

The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

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

First Submitted

Initial submission to the registry

October 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

October 28, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 24, 2017

Completed
Last Updated

July 2, 2018

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

October 13, 2015

Results QC Date

March 9, 2017

Last Update Submit

May 31, 2018

Conditions

MyopiaHyperopia

Outcome Measures

Primary Outcomes (1)

  • Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative

    Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.

    Month 3 postoperative

Secondary Outcomes (9)

  • Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative

    Month 1 postoperative

  • Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative

    Month 1, Month 3 postoperative

  • Ease of Flap Dissection at Day 0, Operative Day

    Day 0, operative day

  • Stromal Bed Quality at Day 0, Operative Day

    Day 0, operative day

  • Opaque Bubble Layer (OBL) at Day 0, Operative Day

    Day 0, operative day

  • +4 more secondary outcomes

Study Arms (1)

LenSx

EXPERIMENTAL

LASIK surgery in both eyes using LenSx® Femtosecond Laser System

Device: Femtosecond Laser SystemProcedure: LASIK surgery

Interventions

Femtosecond Laser SystemDEVICE

Used for the creation of a corneal flap in patients undergoing LASIK surgery

Also known as: LenSx®
LenSx
LASIK surgeryPROCEDURE
LenSx

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with myopia or hyperopia and eligible for femtosecond laser initiated LASIK surgery;
  • Best corrected visual acuity (BCVA) correctable to at least 20/25 in each eye;
  • If contact lens wearer, willing to discontinue contact lens wear prior to screening procedures;
  • Willing and able to return for ALL scheduled follow-up examinations;
  • Willing and able to provide written informed consent;
  • Eligible for bilateral LASIK procedures to be done on the same day;

You may not qualify if:

  • Previous corneal surgery, corneal lesions that will impede laser treatment, corneal edema, hypotony, glaucoma, existing corneal implant, or keratoconus;
  • Known sensitivity to planned study concomitant medications;
  • Participation in any other ophthalmic drug or device clinical study for 30 days prior to or during the time of participation in this study;
  • Irregular astigmatism, based on the Investigator's judgement;
  • Pregnant, lactating or planning to become pregnant during the course of the study;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

MyopiaHyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Global Brand Med Affairs Lead, CDMA Surgical
Organization
Alcon, A Novartis Division
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Clinical Trial Manager, GCRA

    Alcon, A Novartis Division

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 15, 2015

Study Start

October 28, 2015

Primary Completion

April 9, 2016

Study Completion

April 9, 2016

Last Updated

July 2, 2018

Results First Posted

May 24, 2017

Record last verified: 2017-04

Locations

US(1)