Safety and Effectiveness of Arcuate Incisions Performed With the iFS Femtosecond Laser System
This study has been completed.
Sponsor:
Abbott Medical Optics
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01348854
First received: May 4, 2011
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
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: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent of eyes with loss of >/= 2 lines of BSCVA [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 33 |
| 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
Subjects with corneal astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.
|
Device: iFS Femtosecond Laser System
arcuate incisions placed with the iFS femtosecond laser
|
|
Experimental: Post cataract with residual astigmatism
Subjects who have had cataract removal surgery but have residual astigmatism. May also include subjects who have had a phakic intraocular lens implanted with residual astigmatism.
|
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:
- 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
- Willing and capable of returning for follow-up examinations for the duration of the study
Exclusion Criteria:
- 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
Contacts and Locations
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 |
| Last Updated: | May 16, 2013 |
| 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 May 16, 2013