Corneal AstigmatismPhase 2NCT01348854

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

A Phase 2 study testing iFS Femtosecond Laser System in people with Corneal Astigmatism, run by Abbott Medical Optics at 4 sites in 3 countries.

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

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

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Corneal 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: 40 participants
Where: 4 sitesin 3 countries
Study dates: May 2011to Apr 2013
Phase: Phase 2
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
Healthy volunteers accepted
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 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

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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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

Germany2 sites

Bochum-Langendreer
Bochum, Bochum, 44892
Potsdamer Augenklinik im
Potsdam, Potsdam, 14467

Other trials in Germany

Austria1 site

Paracelsus Medizinische Privat-Universitat, PMU
Salzburg, State of Salzburg, A5020

Other trials in Austria

France1 site

CHU Morvan
Brest, Brest, 29609

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions: Corneal Astigmatism
Being tested: iFS Femtosecond Laser System
Keywords: astigmatism
Medical subject headings: Astigmatism

What participants receive

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

iFS Femtosecond Laser SystemDevice
arcuate incisions placed with the iFS femtosecond laser

Study groups in NCT01348854
Study group	Role	What they receive
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. Receives: 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. Receives: Device: iFS Femtosecond Laser System

What is being measured

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

Reduction of Astigmatism
Reduction of astigmatism as determined by manifest refractive cylinder
Measured: 6 months

Secondary outcomes (1)

Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)
Measured: 6 months

Timeline

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

May 2011Apr 2013

First posted6 May 2011 (estimated)
Study startMay 2011
Primary completionApr 2013
Study completionApr 2013

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 Corneal 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01348854
Sponsor's protocol ID: FMTO-103-ISAK
Status last verified: May 2014
First submitted: 4 May 2011
Last updated: 4 Jun 2014
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

RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
RecruitingObservational study
Accuracy of Corneal Astigmatism in Different Region Modes
Astigmatism, Cornea
RecruitingObservational study
Corneal Biomechanics and Surgically Induced Astigmatism in Pseudoexfoliation Syndrome
Pseudoexfoliation Syndrome, Cataract
Active, not recruiting
Influence of Implantation Technique on Rotational Stability of a Frosted-Haptic Toric Intraocular Lens: A Prospective Contralateral-Eye Study
Cataract With Pre-existing Regular Corneal Astigmatism
Active, not recruiting
Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism
Hyperopia, High Astigmatism

All Corneal Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center Prospective Study to Evaluate the Safety and Effectiveness of Arcuate Incisions Performed With the IntraLase iFS Femtosecond Laser System
ClinicalTrials.gov ID: NCT01348854
Acronym / sponsor ID: FMTO-103-ISAK
Conditions: Corneal Astigmatism
Keywords: astigmatism
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Abbott Medical OpticsIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 6 May 2011 (estimated)
Results: Posted 4 Jun 2014

Clinical summary

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

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

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 design

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

Arm	Type	Receives
Natural Astigmatism	Experimental	Device: iFS Femtosecond Laser SystemUse 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.
Post Cataract with Residual Astigmatism	Experimental	Device: iFS Femtosecond Laser SystemUse 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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: 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 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)
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.

Key exclusion criteria (10 listed)

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

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 Systemarcuate incisions placed with the iFS femtosecond laser	Device	Natural Astigmatism, Post Cataract with Residual Astigmatism

Primary outcome

Reduction of Astigmatism
Time frame: 6 months
Reduction of astigmatism as determined by manifest refractive cylinder

1 secondary outcome

Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)
Time frame: 6 months

Results and safety

Results posted to the registry on 4 Jun 2014, 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	34	31
Post Cataract With Residual Astigmatism	6	5

Primary outcome: Reduction of Astigmatism

Time frame: 6 months. Mean (Standard Deviation). Unit: diopter

Measure	Natural Astigmatism n = 32	Post Cataract With Residual Astigmatism n = 4
Value	-0.75 (0.94)	-0.88 (0.26)

Population analysed: Data analysis was performed for eyes treated. Subjects may have had one or both eyes treated. If both eyes, one eye may have been in Natural Astigmatism group and the other eye in the Post Cataract with Residual Astigmatism group.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Natural Astigmatism	1 of 34 (2.9%)	1 of 34 (2.9%)	Not reported
Post Cataract With Residual Astigmatism	1 of 6 (16.7%)	1 of 6 (16.7%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Corneal Astigmatism

RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
RecruitingObservational study
Accuracy of Corneal Astigmatism in Different Region Modes
Astigmatism, Cornea
RecruitingObservational study
Corneal Biomechanics and Surgically Induced Astigmatism in Pseudoexfoliation Syndrome
Pseudoexfoliation Syndrome, Cataract
Active, not recruiting
Influence of Implantation Technique on Rotational Stability of a Frosted-Haptic Toric Intraocular Lens: A Prospective Contralateral-Eye Study
Cataract With Pre-existing Regular Corneal Astigmatism
Active, not recruiting
Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism
Hyperopia, High 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

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing iFS Femtosecond Laser System in people with Corneal Astigmatism, run by Abbott Medical Optics at 4 sites in 3 countries.

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 10 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 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Austria, France. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2014). 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?

Reduction of Astigmatism (time frame: 6 months). 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 NCT01348854.

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 4 Jun 2014.