A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

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

Comparing LASIK outcomes using two femtosecond lasers

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: Intralase IFS150; Device: Visumax

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Byers Eye Institute at Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ETDRS Uncorrected Visual Acuity	Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts	At post-operative month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness	Anterior segment ocular coherence tomography	At postoperative month one
Cochet Bonnet Asthesiometry Measurement of Corneal Sensation	Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal.	At postoperative month twelve
Best Spectacle Corrected Visual Acuity	Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts	Postoperative month 12
Aberrometry	Aberrometry images will be obtained on the iDesign aberrometer	One three, six and twelve months
Questionnaire Measuring Patient Preference for Laser Device	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.	Intraoperative (Approximately 1 minute after completion of surgery)
Patient Reported Outcomes With LASIK	PROWL study questionnaire	One month, three months, six months and twelve months

Collaborators and Investigators

• Sponsor: Edward E. Manche
• Investigators: Principal Investigator: Edward Manche, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 14, 2017
• Primary Completion (ACTUAL): November 13, 2018
• Study Completion (ACTUAL): November 13, 2018

Study Registration Dates

• First Submitted: February 11, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (ACTUAL): February 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Femtosecond laser; LASIK; Visumax; Intralase IFS150
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: 33356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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