An Outcomes Study Comparing the Intralase FS 60 to the Intralase iFS When Performing LASIK Surgery for Nearsightedness
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ClinicalTrials.gov Identifier: NCT01365728 |
Recruitment Status :
Completed
First Posted : June 3, 2011
Last Update Posted : March 7, 2019
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Condition or disease | Intervention/treatment |
---|---|
Myopia Astigmatism | Procedure: LASIK with the iFS femtosecond laser |
Study Type : | Observational |
Actual Enrollment : | 61 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK With the Intralase FS 60 Versus the Intralase IFS |
Actual Study Start Date : | April 2011 |
Actual Primary Completion Date : | December 2018 |
Actual Study Completion Date : | December 2018 |

- Procedure: LASIK with the iFS femtosecond laser
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.
- Changes in Best Spectacle Corrected Visual Acuity [ Time Frame: One year ]
- Changes in 5% low contrast best corrected visual acuity [ Time Frame: One year ]
- Changes in corneal sensation [ Time Frame: One year ]
- Uncorrected Visual Acuity [ Time Frame: One year ]
- Stability of refractive outcome [ Time Frame: One year ]
- Changes in 25% low contrast best corrected visual acuity [ Time Frame: One year ]
- Subjective Questionnaire [ Time Frame: 1 yr ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365728
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Edward E. Manche | Stanford University |
Responsible Party: | Edward E. Manche, Professor of Ophthalmology, Stanford University |
ClinicalTrials.gov Identifier: | NCT01365728 History of Changes |
Other Study ID Numbers: |
SU-05212011-7804 Stanford IRB Protocol # 21250 |
First Posted: | June 3, 2011 Key Record Dates |
Last Update Posted: | March 7, 2019 |
Last Verified: | March 2019 |
Femtosecond Laser FS60 iFS Intralase Wavefront-guided LASIK |
IntraLASIK LASIK Myopia Nearsightedness |
Myopia Astigmatism Refractive Errors Eye Diseases |