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A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03063164
Recruitment Status : Completed
First Posted : February 24, 2017
Results First Posted : December 14, 2021
Last Update Posted : December 14, 2021
Information provided by (Responsible Party):
Edward E. Manche, Stanford University

Brief Summary:
Comparing LASIK outcomes using two femtosecond lasers

Condition or disease Intervention/treatment Phase
Myopia Astigmatism Device: Intralase IFS150 Device: Visumax Not Applicable

Detailed Description:
Patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then the investigator will inform the patient and make an appropriate referral. Patients deemed appropriate for the study after a comprehensive examination including computerized videokeratography can be enrolled. Patients will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase IFS 150 and which eye is treated with VisuMax will be randomized so there is a 50% chance for either eye to receive one treatment. Patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. Patients will receive topical antibiotics in each eye for one week following the procedure. Patients will receive pred forte 1% ophthalmic drops for one week after treatment. Patients will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eye to eye comparison
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Fellow Eye Comparison of Fellow Eyes Undergoing LASIK With the Intralase IFS150 Versus the Visumax
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : November 13, 2018
Actual Study Completion Date : November 13, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Intralase IFS
Intralase IFS vs. Visumax
Device: Intralase IFS150
Intralase flap creation

Active Comparator: Visumax
Visumax vs. Intralase iFS
Device: Visumax
Visumax flap creation

Primary Outcome Measures :
  1. ETDRS Uncorrected Visual Acuity [ Time Frame: At post-operative month 12 ]
    Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts

Secondary Outcome Measures :
  1. Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness [ Time Frame: At postoperative month one ]
    Anterior segment ocular coherence tomography

  2. Cochet Bonnet Asthesiometry Measurement of Corneal Sensation [ Time Frame: At postoperative month twelve ]
    Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal.

  3. Best Spectacle Corrected Visual Acuity [ Time Frame: Postoperative month 12 ]
    Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts

  4. Aberrometry [ Time Frame: One three, six and twelve months ]
    Aberrometry images will be obtained on the iDesign aberrometer

  5. Questionnaire Measuring Patient Preference for Laser Device [ Time Frame: Intraoperative (Approximately 1 minute after completion of surgery) ]
    Participants were asked if they preferred having LASIK surgery with either the Visumax laser, the Intralase iFS laser or had no preference between the two lasers.

  6. Patient Reported Outcomes With LASIK [ Time Frame: One month, three months, six months and twelve months ]
    PROWL study questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects age 21 and older with healthy eyes. Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.

Exclusion Criteria:

  • Subjects under the age of 21
  • Subjects over the age of 60
  • Subjects with corneal ectatic disorders

Information from the National Library of Medicine

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): NCT03063164

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United States, California
Byers Eye Institute at Stanford
Palo Alto, California, United States, 94303
Sponsors and Collaborators
Edward E. Manche
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Principal Investigator: Edward Manche, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Edward E. Manche, Stanford University:
Study Protocol  [PDF] March 6, 2018
No Statistical Analysis Plan (SAP) exists for this study.

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Responsible Party: Edward E. Manche, Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT03063164    
Other Study ID Numbers: 33356
First Posted: February 24, 2017    Key Record Dates
Results First Posted: December 14, 2021
Last Update Posted: December 14, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Edward E. Manche, Stanford University:
Femtosecond laser
Intralase IFS150
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases