Refractive AstigmatismNCT01210820

Feasibility of iFS™ for Intrastromal Arcuate Keratotomy (ISAK) Procedures

A study testing iFS™ Femtosecond Laser System in people with Refractive Astigmatism, run by Abbott Medical Optics at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The results of this trial will demonstrate that ISAK performed with the iFS™ femtosecond laser is a safe procedure. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Refractive Astigmatism
What is being tested?: iFS™ Femtosecond Laser System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteAustria
Study dates: Jul 2010to Jun 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, of any race, and at least 21 years of age at the time of the pre-operative examination and signing the consent form
Refractive error, no limitation on spherical refractive myopia or hyperopia and refractive astigmatism of 0.75 to 7.00 diopters (D) in the operative eye
Best Spectacle Corrected Distance Visual Acuity (BSCVA)
Group 1: Natural astigmatism, no cataract: BSCVA of 20/25 or better in both eyes
Group 1: Pre cataract surgery, no BSCVA criteria in the operative eye
Group 2: Post cataract surgery, BSCVA of 20/25 or better in both eyes

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Uncorrected Visual Acuity (UCVA) of 20/40 or worse in the operative eye
Demonstration of agreement in the operative eye: Corneal astigmatism (as determined by keratometry) must be in agreement with refractive astigmatism (as determined by manifest refractions) as follows: Within ≤ 0.75 D in magnitude and within 15° axis when cylinder ≤ 1.5 D or 10° axis when cylinder > 1.5 D.
Preoperative central and peripheral (in planned treatment area) pachymetry of ≥ 500 um in the operative eye
Keratometry must be between 38.0 (flat) and 48.0 D (steep) in the operative eye
Corneal power (diopters) difference at the 3mm point from topographic center shall be ≤ 1D at the steepest meridian, by topography measurements in the operative eye
Intraocular pressure (IOP) of 12 to 21 mm Hg in the operative eye with no glaucomatous retinal changes
Stable refractive error in the operative eye, based on an exam (or prescription) at least 6 months prior to the pre-operative examination, and as compared to the pre-operative manifest refraction, must be ≤ 0.75 D (sphere and cylinder) and axis within 15 degrees for eyes with cylinder > 0.5D.
Subjects who have worn a contact lens in the operative eye 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. In addition, rigid or toric lens wearers must demonstrate stability in topography, keratometry and refraction before proceeding with surgery. Refractive stability is defined as a change of not more than 0.50 D in manifest sphere, cylinder, or keratometry (either axis) as compared to the unadjusted preoperative refraction in two visits at least one week apart.
Willing and capable of returning for follow-up examinations for the duration of the study
Subject must sign and be given a copy of the written Informed Consent Form

Who cannot join

Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration, in either eye
Irregular astigmatism in the operative eye
Evidence of clinically significant corneal opacity/scar in the operative eye within an 8 mm diameter zone of the visual axis
Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study, as determined by verbal inquiry
Concurrent use of topical or systemic medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment
History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis

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History of active ophthalmic disease or other non-refractive abnormality (including, but not limited to, corneal dystrophy, symptomatic blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1mm from limbus), retinal detachment/repair, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma NOTE: Subjects with open angle glaucoma, regardless of medication regimen or control, or an IOP greater than 21 mm Hg at baseline, are specifically excluded from eligibility.
Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
Participation in any other conflicting ophthalmic drug or device clinical study during the period of participation in this clinical investigation -

Trial locations and contacts

1 site in 1 country.

Austria1 site

Paracelsus Medizinische Privat-Universitat, PMU
Salzburg, State of Salzburg, 5020

Other trials in Austria

About this study

Official title: A Prospective Single Center Study To Evaluate the Feasibility of Intrastromal Arcuate Keratotomy Performed With the IntraLase iFS™ Femtosecond Laser System

The results of this trial will demonstrate that ISAK performed with the iFS™ femtosecond laser is a safe procedure.

Read the detailed description

Surgeon will perform intrastromal arcuate keratotomy in arc segment patterns using the iFS™ femtosecond laser to treat subjects with refractive astigmatism.

Conditions: Refractive Astigmatism
Being tested: iFS™ Femtosecond Laser System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iFS™ Femtosecond Laser SystemDevice
Also called iFS™ is part of the product brand name - there is no expanded acronym
intrastromal arcuate cuts made with iFS™ femtosecond laser

Study groups in NCT01210820
Study group	Role	What they receive
Natural Astigmatism	Experimental	Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts. Receives: Device: iFS™ Femtosecond Laser System
Post cataract with residual astigmatism	Experimental	Subjects who have had cataract removal surgery but have residual astigmatism. Receives: Device: iFS™ Femtosecond Laser System

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Refractive Astigmatism
Change in mean cylinder (assessed by manifest refraction) compared to baseline.
Measured: 6 months
Change in Keratometric Cylinder
Change in mean keratometric cylinder (as measured by keratometry) compared to baseline.
Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Jun 2012

First posted29 Sep 2010 (estimated)
Study startJul 2010
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Refractive AstigmatismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01210820
Sponsor's protocol ID: FMTO-102-ISAK
Status last verified: Apr 2013
First submitted: 24 Sep 2010
Last updated: 1 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Refractive Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Single Center Study To Evaluate the Feasibility of Intrastromal Arcuate Keratotomy Performed With the IntraLase iFS™ Femtosecond Laser System
ClinicalTrials.gov ID: NCT01210820
Acronym / sponsor ID: FMTO-102-ISAK
Conditions: Refractive Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Abbott Medical OpticsIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 29 Sep 2010 (estimated)
Results: Posted 26 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The results of this trial will demonstrate that ISAK performed with the iFS™ femtosecond laser is a safe procedure.

Detailed description

Surgeon will perform intrastromal arcuate keratotomy in arc segment patterns using the iFS™ femtosecond laser to treat subjects with refractive astigmatism.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Natural Astigmatism	Experimental	Device: iFS™ Femtosecond Laser SystemSubjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.
Post cataract with residual astigmatism	Experimental	Device: iFS™ Femtosecond Laser SystemSubjects who have had cataract removal surgery but have residual astigmatism.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Male or female, of any race, and at least 21 years of age at the time of the pre-operative examination and signing the consent form
Refractive error, no limitation on spherical refractive myopia or hyperopia and refractive astigmatism of 0.75 to 7.00 diopters (D) in the operative eye
Best Spectacle Corrected Distance Visual Acuity (BSCVA)
Uncorrected Visual Acuity (UCVA) of 20/40 or worse in the operative eye
Demonstration of agreement in the operative eye: Corneal astigmatism (as determined by keratometry) must be in agreement with refractive astigmatism (as determined by manifest refractions) as follows: Within ≤ 0.75 D in magnitude and within 15° axis when cylinder ≤ 1.5 D or 10° axis when cylinder > 1.5 D.

Key exclusion criteria (9 listed)

Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration, in either eye
Irregular astigmatism in the operative eye
Evidence of clinically significant corneal opacity/scar in the operative eye within an 8 mm diameter zone of the visual axis
Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study, as determined by verbal inquiry
Concurrent use of topical or systemic medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
iFS™ Femtosecond Laser SystemAlso: iFS™ is part of the product brand name - there is no expanded acronymintrastromal arcuate cuts made with iFS™ femtosecond laser	Device	Natural Astigmatism, Post cataract with residual astigmatism

Primary outcome

Change in Refractive Astigmatism
Time frame: 6 months
Change in mean cylinder (assessed by manifest refraction) compared to baseline.
Change in Keratometric Cylinder
Time frame: 6 Months
Change in mean keratometric cylinder (as measured by keratometry) compared to baseline.

Results and safety

Results posted to the registry on 26 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Natural Astigmatism	17	17
Post Cataract With Residual Astigmatism	4	4

Primary outcome: Change in Refractive Astigmatism

Time frame: 6 months. Mean (Standard Deviation). Unit: Diopter of cylinder change

Measure	Natural Astigmatism n = 17	Post Cataract With Residual Astigmatism n = 4
Value	-0.97 (0.43)	-0.81 (0.35)

Primary outcome: Change in Keratometric Cylinder

Time frame: 6 Months. Mean (Standard Deviation). Unit: Diopters of astigmatism change

Measure	Natural Astigmatism n = 17	Post Cataract With Residual Astigmatism n = 4
Value	-0.81 (0.62)	-0.63 (0.78)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Natural Astigmatism	0 of 17 (0%)	0 of 17 (0%)	Not reported
Post Cataract With Residual Astigmatism	0 of 4 (0%)	0 of 4 (0%)	Not reported

Limitations and caveats (from the sponsor): This evaluation was performed on a small number of subjects and should be repeated in a larger number of subjects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Refractive Astigmatism

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
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Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicholas Tarantino, OD study director

Abbott Medical Optics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing iFS™ Femtosecond Laser System in people with Refractive Astigmatism, run by Abbott Medical Optics at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Refractive Astigmatism (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01210820.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2013.