NCT01695642

Brief Summary

Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed for correction of myopia. There are very few studies that have been performed to evaluate long-term outcomes after LASIK. In this study, we will assess long-term outcomes 5 - 10 years after LASIK to assess stability of visual outcomes and long-term effect on corneal morphology with in vivo confocal microscopy. Clinical and corneal morphology outcomes will also be compared between patients who had flaps created with the microkeratome and femtosecond laser.

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 all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 20, 2017

Status Verified

March 1, 2017

Enrollment Period

2.5 years

First QC Date

September 26, 2012

Last Update Submit

March 16, 2017

Conditions

Lasik Eye Surgery

Keywords

lasik, intralase, microkeratome

Outcome Measures

Primary Outcomes (1)

  • Compare flap creation with mikrokeratome and Intralase

    8 to 10 years

Study Arms (2)

Microkeratome

mechanical microkeratome

Intralase

femtosecond laser

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All subjects who had LASIK surgery for correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap creation between 2002 to 2005.

You may qualify if:

  • lasik surgery at the kellogg eye center between 2002 and 2005; at least 3 months of follow up after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Study Officials

  • Roni Shtein, MD, MS

    University of Michigan Kellogg Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology and Visual Sciences

Study Record Dates

First Submitted

September 26, 2012

First Posted

September 28, 2012

Study Start

June 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2016

Last Updated

March 20, 2017

Record last verified: 2017-03

Locations

US(1)