An Outcomes Study Comparing the Intralase FS 60 to the Intralase iFS When Performing LASIK Surgery for Nearsightedness

Myopia Clinical Trial

Official title:

A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK With the Intralase FS 60 Versus the Intralase IFS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365728
• Other study ID #: SU-05212011-7804
• Secondary ID: Stanford IRB Pro
• Status: Completed
• Start date: April 2011
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to compare the results of LASIK surgery when using two versions of a femtosecond laser in patients with nearsightedness with and without astigmatism.

Description:

The 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 we will inform the patient and make an appropriate referral. if the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase FS 60 and which eye is treated with Intralase IFS will be randomized so there is a 50% chance for either eye to receive one treatment. The patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. The patient will receive pred forte 1% ophthalmic drops for one week after treatment. The patient 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: 61
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Best Spectacle Corrected Visual Acuity		One year
Primary	Changes in 5% low contrast best corrected visual acuity		One year
Primary	Changes in corneal sensation		One year
Primary	Uncorrected Visual Acuity		One year
Primary	Stability of refractive outcome		One year
Primary	Changes in 25% low contrast best corrected visual acuity		One year
Secondary	Subjective Questionnaire		1 yr