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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edward E. Manche, Stanford University
ClinicalTrials.gov Identifier:
NCT01365728
First received: June 1, 2011
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Myopia
Astigmatism
 Procedure: LASIK with the iFS femtosecond laser

Study Type: Observational
Study Design: 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

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Changes in Best Spectacle Corrected Visual Acuity [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Changes in 5% low contrast best corrected visual acuity [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Changes in corneal sensation [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Uncorrected Visual Acuity [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Stability of refractive outcome [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Changes in 25% low contrast best corrected visual acuity [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective Questionnaire [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Myopic eyes undergoing LASIK with 2 femtosescond lasers 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.

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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365728

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

No publications provided

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
Study First Received: June 1, 2011
Last Updated: October 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Femtosecond Laser
FS60
iFS
Intralase
Wavefront-guided LASIK
 IntraLASIK
LASIK
Myopia
Nearsightedness

Additional relevant MeSH terms:
Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013