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Safety and Effectiveness of Arcuate Incisions Performed With the iFS Femtosecond Laser System

This study has been completed.
Information provided by (Responsible Party):
Abbott Medical Optics Identifier:
First received: May 4, 2011
Last updated: May 6, 2014
Last verified: May 2014
To determine if arcuate incisions performed with the iFS femtosecond laser are safe and effective in reducing corneal astigmatism.

Condition Intervention Phase
Corneal Astigmatism
Device: iFS Femtosecond Laser System
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Prospective Study to Evaluate the Safety and Effectiveness of Arcuate Incisions Performed With the IntraLase iFS Femtosecond Laser System

Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Reduction of Astigmatism [ Time Frame: 6 months ]
    Reduction of astigmatism as determined by manifest refractive cylinder

Secondary Outcome Measures:
  • Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 6 months ]

Enrollment: 40
Study Start Date: May 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Natural Astigmatism
Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
Device: iFS Femtosecond Laser System
arcuate incisions placed with the iFS femtosecond laser
Experimental: Post Cataract with Residual Astigmatism
Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
Device: iFS Femtosecond Laser System
arcuate incisions placed with the iFS femtosecond laser

Detailed Description:
Surgeons will perform arcuate incisions in the cornea in arc segment patterns using the iFS femtosecond laser to treat subjects with corneal astigmatism.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Male or female, of any race, and at least 21 years of age at the time of pre-op exam
  2. Corneal astigmatism, as determined by topographic keratometry, of 0.75 D to 4.00 diopters (D)
  3. Best Spectacle Corrected Distance Visual Acuity (BSCVA)

    1. Group 1:

      • Natural astigmatism, no cataract - BSCVA of 20/25 or better
      • Pre cataract or phakic IOL surgery - no BSCVA criteria
    2. Group 2:

      • Post IOL surgery- BSCVA of 20/25 or better
  4. Uncorrected Visual Acuity (UCVA) of 20/40 or worse
  5. Demonstration of agreement: Corneal astigmatism (as determined by topographic keratometry) must be in agreement with refractive astigmatism (as determined by manifest refractions) within </= 0.75 D in magnitude and 15 degrees axis when cylinder </= 1.5 D or 10 degrees axis when cylinder > 1.5 D.
  6. Preoperative central pachymetry of >/=480 um
  7. Keratometry between 38.0 D (flat) to 48.0 D (steep)
  8. Corneal power (diopters) difference at the 3mm point from topographic center shall be </= 1D at the steepest meridian
  9. Intraocular pressure of 12 to 21 mm Hg with no glaucomatous retinal/optic nerve changes
  10. Subjects who have worn a contact lens within the past 30 days must remove the soft lens at least 2 weeks prior and a rigid or toric lens at least 3 weeks prior to baseline measurements
  11. Willing and capable of returning for follow-up examinations for the duration of the study

Exclusion Criteria:

  1. Angle kappa of greater than 0.5 mm, absolute value
  2. Prior implantation of toric or multifocal intraocular lens
  3. Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
  4. Concurrent use of topical or systemic medications that may impair corneal wound healing
  5. History of any ocular or medical conditions that could affect corneal wound healing
  6. History of active or recurrent ophthalmic disease, including corneal dystrophy or other non-refractive abnormality such as exposure keratitis or clinically significant dry eye
  7. Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration in either eye
  8. Evidence of clinically significant corneal opacity/scar in the operative eye(s) within an 8 mm diameter zone of the visual axis
  9. Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
  10. Participation in any other conflicting clinical study
  Contacts and Locations
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Please refer to this study by its identifier: NCT01348854

Paracelsus Medizinische Privat-Universitat, PMU
Salzburg, Austria, A5020
CHU Morvan
Brest, France, 29609
Bochum, Germany, 44892
Potsdamer Augenklinik im
Potsdam, Germany, 14467
Sponsors and Collaborators
Abbott Medical Optics
Study Director: Nicholas Tarantino, OD Abbott Medical Optics
  More Information

Responsible Party: Abbott Medical Optics Identifier: NCT01348854     History of Changes
Other Study ID Numbers: FMTO-103-ISAK
Study First Received: May 4, 2011
Results First Received: January 31, 2014
Last Updated: May 6, 2014

Keywords provided by Abbott Medical Optics:

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases processed this record on May 25, 2017