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OpenTrials
Completed

NCT Number: NCT03063164

A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

Comparing LASIK outcomes using two femtosecond lasers

Completed

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intralase IFS150

Device

Intralase flap creation

Visumax

Device

Visumax flap creation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Edward E. Manche

Other

Registry information

Official study title

A Prospective, Randomized, Fellow Eye Comparison of Fellow Eyes Undergoing LASIK With the Intralase IFS150 Versus the Visumax

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 24, 2017
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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