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

Corneal Astigmatism Clinical Trial

Official title:

A Multi-Center Prospective Study to Evaluate the Safety and Effectiveness of Arcuate Incisions Performed With the IntraLase iFS Femtosecond Laser System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348854
• Other study ID #: FMTO-103-ISAK
• Status: Completed
• Phase: Phase 2
• First received: May 4, 2011
• Last updated: May 6, 2014
• Start date: May 2011
• Est. completion date: April 2013

Study information

• Verified date: May 2014
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Austria: Federal Ministry for Health Family and Youth
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Corneal Astigmatism

Intervention

Device:
• iFS Femtosecond Laser System
arcuate incisions placed with the iFS femtosecond laser

Locations

Country	Name	City	State
Austria	Paracelsus Medizinische Privat-Universitat, PMU	Salzburg
France	CHU Morvan	Brest
Germany	Bochum-Langendreer	Bochum
Germany	Potsdamer Augenklinik im	Potsdam

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Countries where clinical trial is conducted

Austria,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of Astigmatism	Reduction of astigmatism as determined by manifest refractive cylinder	6 months	No
Secondary	Percent of Eyes With Loss of = 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)		6 months	Yes