NCT00691431

Brief Summary

This study compared the clinical outcomes between fellow eyes randomized to either IntraLase femtosecond laser-created flaps or Hansatome mechanical keratome-created flaps during wavefront-guided laser in situ keratomileusis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2004

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, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
Last Updated

June 2, 2011

Status Verified

June 1, 2008

First QC Date

June 3, 2008

Last Update Submit

June 1, 2011

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

Secondary Outcomes (1)

  • Contrast sensitivity

Interventions

LASIKDEVICE

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, 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

  • Edward E. Manche

    Stanford University

    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

June 3, 2008

First Posted

June 5, 2008

Study Start

May 1, 2004

Study Completion

November 1, 2005

Last Updated

June 2, 2011

Record last verified: 2008-06

Locations

US(1)