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

NCT01348854 | Completed Phase 2 Results

• 1 other identifier: FMTO-103-ISAK
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 4

Brief Summary

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

Conditions

Corneal Astigmatism

Keywords

astigmatism

Outcome Measures

Primary Outcomes (1)

• Reduction of Astigmatism

  Reduction of astigmatism as determined by manifest refractive cylinder

  6 months

Secondary Outcomes (1)

• Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)

  6 months

Study Arms (2)

Natural Astigmatism

EXPERIMENTAL

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

Post Cataract with Residual Astigmatism

EXPERIMENTAL

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

Interventions

iFS Femtosecond Laser System DEVICE

arcuate incisions placed with the iFS femtosecond laser

Natural Astigmatism; Post Cataract with Residual Astigmatism

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, of any race, and at least 21 years of age at the time of pre-op exam
• Corneal astigmatism, as determined by topographic keratometry, of 0.75 D to 4.00 diopters (D)
• Best Spectacle Corrected Distance Visual Acuity (BSCVA)
• Group 1:
• Natural astigmatism, no cataract - BSCVA of 20/25 or better
• Pre cataract or phakic IOL surgery - no BSCVA criteria
• Group 2:
• Post IOL surgery- BSCVA of 20/25 or better
• Uncorrected Visual Acuity (UCVA) of 20/40 or worse
• 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.
• Preoperative central pachymetry of \>/=480 um
• Keratometry between 38.0 D (flat) to 48.0 D (steep)
• Corneal power (diopters) difference at the 3mm point from topographic center shall be \</= 1D at the steepest meridian
• Intraocular pressure of 12 to 21 mm Hg with no glaucomatous retinal/optic nerve changes
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Abbott Medical Optics: lead

Study Sites (4)

Paracelsus Medizinische Privat-Universitat, PMU

Salzburg, Salzburg, A5020, Austria

Location

CHU Morvan

Brest, Brest, 29609, France

Location

Bochum-Langendreer

Bochum, Bochum, 44892, Germany

Location

Potsdamer Augenklinik im

Potsdam, Potsdam, 14467, Germany

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

BSCVA determination in eyes with progressing cataracts was sometimes unevaluable, although data are shown as reported. The number of eyes in "Post Cataract Surgery with Astigmatism" Arm was small, limiting data analysis.

Results Point of Contact

• Title: Carrie Garufis
• Organization: Abbott Medical Optics

carrie.garufis@amo.abbott.com

714-247-8200

Study Officials

• Nicholas Tarantino, OD

  Abbott Medical Optics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 6, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 4, 2014
• Results First Posted: June 4, 2014

Record last verified: 2014-05

Locations

AU (1); DE (2); FR (1)