A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063164
• Other study ID #: 33356
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: November 13, 2018

Study information

• Verified date: November 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparing LASIK outcomes using two femtosecond lasers

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 13, 2018
• Est. primary completion date: November 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• Intralase IFS150
Intralase flap creation
• Visumax
Visumax flap creation

Locations

Country	Name	City	State
United States	Byers Eye Institute at Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Edward E. Manche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness	Anterior segment ocular coherence tomography	At postoperative month one
Secondary	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
Secondary	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
Secondary	Aberrometry	Aberrometry images will be obtained on the iDesign aberrometer	One three, six and twelve months
Secondary	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)
Secondary	Patient Reported Outcomes With LASIK	PROWL study questionnaire	One month, three months, six months and twelve months