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

NCT ID: NCT01365728

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2018-12-31

Brief 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.

Detailed 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.

Conditions

Myopia; Astigmatism

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Edward E. Manche

Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward E. Manche

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

Stanford IRB Protocol # 21250

Identifier Type: -

Identifier Source: secondary_id

SU-05212011-7804

Identifier Type: -

Identifier Source: org_study_id