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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01348854
First received: May 4, 2011
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Reduction of Astigmatism [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348854

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

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov 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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Austria: Federal Ministry for Health Family and Youth

Keywords provided by Abbott Medical Optics:
astigmatism

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 25, 2014