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

• ClinicalTrials.gov Identifier: NCT01365728
• Recruitment Status: Completed
• First Posted: June 3, 2011
• Last Update Posted: March 7, 2019
• Sponsor: Stanford University
• Information provided by (Responsible Party): Edward E. Manche, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment
Myopia; Astigmatism	Procedure: LASIK with the iFS femtosecond laser

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 61 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK With the Intralase FS 60 Versus the Intralase IFS
• Actual Study Start Date: April 2011
• Actual Primary Completion Date: December 2018
• Actual Study Completion Date: December 2018

Groups and Cohorts

Intervention Details:

• 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.

Outcome Measures

Primary Outcome Measures :

1. Changes in Best Spectacle Corrected Visual Acuity [ Time Frame: One year ]
2. Changes in 5% low contrast best corrected visual acuity [ Time Frame: One year ]
3. Changes in corneal sensation [ Time Frame: One year ]
4. Uncorrected Visual Acuity [ Time Frame: One year ]
5. Stability of refractive outcome [ Time Frame: One year ]
6. Changes in 25% low contrast best corrected visual acuity [ Time Frame: One year ]

Secondary Outcome Measures :

1. Subjective Questionnaire [ Time Frame: 1 yr ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

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.

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.

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Edward E. Manche; Stanford University

More Information

• Responsible Party: Edward E. Manche, Professor of Ophthalmology, Stanford University
• ClinicalTrials.gov Identifier: NCT01365728 History of Changes
• Other Study ID Numbers: SU-05212011-7804; Stanford IRB Protocol # 21250
• First Posted: June 3, 2011
• Last Update Posted: March 7, 2019
• Last Verified: March 2019

Keywords provided by Edward E. Manche, Stanford University:

Femtosecond Laser; FS60; iFS; Intralase; Wavefront-guided LASIK; IntraLASIK; LASIK; Myopia; Nearsightedness

Additional relevant MeSH terms:

Myopia; Astigmatism; Refractive Errors; Eye Diseases