- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01348854
Safety and Effectiveness of Arcuate Incisions Performed With the iFS Femtosecond Laser System
May 6, 2014 updated by: Abbott Medical Optics
A Multi-Center Prospective Study to Evaluate the Safety and Effectiveness of Arcuate Incisions Performed With the IntraLase iFS Femtosecond Laser System
To determine if arcuate incisions performed with the iFS femtosecond laser are safe and effective in reducing corneal astigmatism.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
arcuate incisions placed with the iFS femtosecond laser
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of Astigmatism
Time Frame: 6 months
|
Reduction of astigmatism as determined by manifest refractive cylinder
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
May 4, 2011
First Submitted That Met QC Criteria
May 4, 2011
First Posted (Estimate)
May 6, 2011
Study Record Updates
Last Update Posted (Estimate)
June 4, 2014
Last Update Submitted That Met QC Criteria
May 6, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMTO-103-ISAK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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