Clinical trial NCT01348854: Safety and Effectiveness of Arcuate Incisions Performed With the iFS Femtosecond Laser System
Official title: A Multi-Center Prospective Study to Evaluate the Safety and Effectiveness of Arcuate Incisions Performed With the IntraLase iFS Femtosecond Laser System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Corneal Astigmatism
Keywords: astigmatism
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2011-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if arcuate incisions performed with the iFS femtosecond laser are safe and effective in reducing corneal astigmatism.

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 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

Primary outcomes:
measure: Reduction of Astigmatism
timeFrame: 6 months
Secondary outcomes:
measure: Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)
timeFrame: 6 months
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Paracelsus Medizinische Privat-Universitat, PMU
city: Brest
country: France
facility: CHU Morvan
city: Bochum
country: Germany
facility: Bochum-Langendreer
city: Potsdam
country: Germany
facility: Potsdamer Augenklinik im
Study officials:
affiliation: Abbott Medical Optics
name: Nicholas Tarantino, OD
role: STUDY_DIRECTOR
References: