NCT02987660

Brief Summary

The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for the treatment of myopia with astigmatism.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

December 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 3, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2017

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 14, 2019

Completed
Last Updated

January 14, 2019

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

December 7, 2016

Results QC Date

July 9, 2018

Last Update Submit

July 9, 2018

Conditions

MyopiaAstigmatism

Outcome Measures

Primary Outcomes (1)

  • Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months

    Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.

    Month 3

Secondary Outcomes (2)

  • Mean Manifest Refraction Cylinder at 3 Months

    Month 3

  • Mean Uncorrected Visual Acuity (UCVA) at 3 Months

    Month 3

Study Arms (2)

LASIK with EX500

EXPERIMENTAL

Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery

Procedure: Topography Guided LASIKDevice: WaveLight EX500 Excimer Laser System

SMILE with VisuMax

ACTIVE COMPARATOR

Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery

Procedure: Small Incision Lenticular ExtractionDevice: VisuMax Surgical Laser

Interventions

Topography Guided LASIKPROCEDURE

Corneal surgery for refractive error correction

LASIK with EX500
Small Incision Lenticular ExtractionPROCEDURE

Refractive surgical procedure for the correction of myopia with or without astigmatism

Also known as: SMILE
SMILE with VisuMax
WaveLight EX500 Excimer Laser SystemDEVICE

As used for corneal stroma ablation (refractive error correction). The treatment is intended to last the subject's lifetime.

LASIK with EX500
VisuMax Surgical LaserDEVICE

As used for lenticule creation/removal (refractive error correction). The treatment is intended to last the subject's lifetime.

SMILE with VisuMax

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects in Singapore must be 21 years of age or older and subjects in Korea must be upon completion of 19 years of age or older due to local regulations;
  • Able to comprehend and sign an informed consent form;
  • Willing and able to complete all postoperative visits;
  • Myopia requiring (a) refractive error correction of -0.5 to -8.0 D optical infinity adjusted manifest refraction sphere with (b) astigmatism correction of -0.75 to -5.0 D manifest refraction cylinder and (c) at least 0.75 D of corneal astigmatism.
  • Intended treatment targeted for emmetropia;
  • Preoperative best-corrected visual acuity (BCVA) of 0 logMAR or better;

You may not qualify if:

  • Pregnant or lactating, current or planned, during the course of the study;
  • Dry eye;
  • Corneal disease;
  • Diagnosis of advanced glaucoma;
  • Uncontrolled diabetes;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Investigative Site

Paris, 75008, France

Location

MeSH Terms

Conditions

MyopiaAstigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

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

Study Officials

  • Alcon, A Novartis Division

    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
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 9, 2016

Study Start

March 3, 2017

Primary Completion

July 26, 2017

Study Completion

July 26, 2017

Last Updated

January 14, 2019

Results First Posted

January 14, 2019

Record last verified: 2018-07

Locations

FR(1)