An Outcomes Study Comparing the Intralase FS 60 to the Intralase iFS When Performing LASIK Surgery for Nearsightedness
A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK With the Intralase FS 60 Versus the Intralase IFS
2 other identifiers
observational
61
1 country
1
Brief Summary
The purpose of the study is to compare the results of LASIK surgery when using two versions of a femtosecond laser in patients with nearsightedness with and without astigmatism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2011
Longer than P75 for all trials
1 active site
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
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 7, 2019
March 1, 2019
7.7 years
June 1, 2011
March 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Changes in Best Spectacle Corrected Visual Acuity
One year
Changes in 5% low contrast best corrected visual acuity
One year
Changes in corneal sensation
One year
Uncorrected Visual Acuity
One year
Stability of refractive outcome
One year
Changes in 25% low contrast best corrected visual acuity
One year
Secondary Outcomes (1)
Subjective Questionnaire
1 yr
Interventions
Patients will undergo bilateral simultaneous LASIK surgery for myopia. One eye will have a LASIK flap created with the Intralase FS60 and the fellow eye will have a LASIK flap created with the Intralase iFS. Both eyes will undergo wavefront-guided LASIK surgery with the Visx CustomVue excimer laser.
Eligibility Criteria
Subjects age 21 and older with healthy eyes. Nearsightedness between -0.25 diopters and -7.00 diopters with or without astigmatism of up to 3.00 diopters.
You may qualify if:
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -0.25 diopters and -7.00 diopters with or without astigmatism of up to 3.00 diopters.
You may not qualify if:
- Subjects under the age of 21.
- Patients with excessively thin corneas.
- Patients with topographic evidence of keratoconus.
- Patients with ectactic eye disorders.
- Patients with autoimmune diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward E. Manche
Stanford University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Ophthalmology
Study Record Dates
First Submitted
June 1, 2011
First Posted
June 3, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
March 7, 2019
Record last verified: 2019-03