NCT00714363

Brief Summary

The objective of the study is to compare clinical outcomes from LASIK and SBK using FDA-approved laser technology on the same patient

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration 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 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 19, 2010

Status Verified

October 1, 2010

Enrollment Period

1.2 years

First QC Date

July 8, 2008

Last Update Submit

October 15, 2010

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    6 months

Secondary Outcomes (2)

  • Manifest refraction

    6 months

  • Wavefront aberration value

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

LASIK

Procedure: LASIK

2

ACTIVE COMPARATOR

SBK

Procedure: SBK

Interventions

LASIKPROCEDURE

Refractive surgery

1
SBKPROCEDURE

Refractive surgery

2

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients deemed to be suitable candidates for bilateral LASIK surgery

You may not qualify if:

  • Patients who desire monovision correction rather than bilateral distance correction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah, John Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures

Study Officials

  • Majid Moshirfar, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 14, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

January 1, 2010

Last Updated

October 19, 2010

Record last verified: 2010-10

Locations

US(1)