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

Sponsor
Abbott Medical Optics (Industry)
Overall Status
Completed
CT.gov ID
NCT01348854
Collaborator
(none)
40
Enrollment
4
Locations
2
Arms
23
Duration (Months)
10
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Device: iFS Femtosecond Laser System
Phase 2

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

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

ArmIntervention/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.

Device: iFS Femtosecond Laser System
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.

Device: iFS Femtosecond Laser System
arcuate incisions placed with the iFS femtosecond laser

Outcome Measures

Primary Outcome Measures

  1. Reduction of Astigmatism [6 months]

    Reduction of astigmatism as determined by manifest refractive cylinder

Secondary Outcome Measures

  1. Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Male or female, of any race, and at least 21 years of age at the time of pre-op exam

  2. Corneal astigmatism, as determined by topographic keratometry, of 0.75 D to 4.00 diopters (D)

  3. Best Spectacle Corrected Distance Visual Acuity (BSCVA)

  4. Group 1:

  • Natural astigmatism, no cataract - BSCVA of 20/25 or better

  • Pre cataract or phakic IOL surgery - no BSCVA criteria

  1. Group 2:
  • Post IOL surgery- BSCVA of 20/25 or better
  1. Uncorrected Visual Acuity (UCVA) of 20/40 or worse

  2. 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.

  3. Preoperative central pachymetry of >/=480 um

  4. Keratometry between 38.0 D (flat) to 48.0 D (steep)

  5. Corneal power (diopters) difference at the 3mm point from topographic center shall be </= 1D at the steepest meridian

  6. Intraocular pressure of 12 to 21 mm Hg with no glaucomatous retinal/optic nerve changes

  7. 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

  8. Willing and capable of returning for follow-up examinations for the duration of the study

Exclusion Criteria:
  1. Angle kappa of greater than 0.5 mm, absolute value

  2. Prior implantation of toric or multifocal intraocular lens

  3. Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study

  4. Concurrent use of topical or systemic medications that may impair corneal wound healing

  5. History of any ocular or medical conditions that could affect corneal wound healing

  6. History of active or recurrent ophthalmic disease, including corneal dystrophy or other non-refractive abnormality such as exposure keratitis or clinically significant dry eye

  7. Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration in either eye

  8. Evidence of clinically significant corneal opacity/scar in the operative eye(s) within an 8 mm diameter zone of the visual axis

  9. Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course

  10. Participation in any other conflicting clinical study

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Paracelsus Medizinische Privat-Universitat, PMUSalzburgAustriaA5020
2CHU MorvanBrestFrance29609
3Bochum-LangendreerBochumGermany44892
4Potsdamer Augenklinik imPotsdamGermany14467

Sponsors and Collaborators

  • Abbott Medical Optics

Investigators

  • Study Director: Nicholas Tarantino, OD, Abbott Medical Optics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01348854
Other Study ID Numbers:
  • FMTO-103-ISAK
First Posted:
May 6, 2011
Last Update Posted:
Jun 4, 2014
Last Verified:
May 1, 2014
Keywords provided by Abbott Medical Optics
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleNatural AstigmatismPost Cataract With Residual Astigmatism
Arm/Group DescriptionUse 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.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.
Period Title: Overall Study
STARTED346
COMPLETED315
NOT COMPLETED31

Baseline Characteristics

Arm/Group TitleNatural AstigmatismPost Cataract With Residual AstigmatismTotal
Arm/Group DescriptionUse 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.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.Total of all reporting groups
Overall Participants34640
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
52.4
(16.6)
55.0
(15.9)
53.7
(16.6)
Sex: Female, Male (Count of Participants)
Female
26
76.5%
5
83.3%
31
77.5%
Male
8
23.5%
1
16.7%
9
22.5%
Region of Enrollment (paticipants) [Number]
France
0
1
1
Austria
17
2
19
Germany
17
3
20

Outcome Measures

1. Primary Outcome
TitleReduction of Astigmatism
DescriptionReduction of astigmatism as determined by manifest refractive cylinder
Time Frame6 months

Outcome Measure Data

Analysis Population Description
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.
Arm/Group TitleNatural AstigmatismPost Cataract With Residual Astigmatism
Arm/Group DescriptionUse 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.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.
Measure Participants324
Measure eyes496
Mean (Standard Deviation) [diopter]
-0.75
(0.94)
-0.88
(0.26)
2. Secondary Outcome
TitlePercent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)
Description
Time Frame6 months

Outcome Measure Data

Analysis Population Description
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.
Arm/Group TitleNatural AstigmatismPost Cataract With Residual Astigmatism
Arm/Group DescriptionUse 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.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.
Measure Participants336
Measure eyes5110
Number [percentage of eyes]
4.9
0

Adverse Events

Time Frame1 year
Adverse Event Reporting Description
Arm/Group TitleNatural AstigmatismPost Cataract With Residual Astigmatism
Arm/Group DescriptionUse 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.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.
All Cause Mortality
Natural AstigmatismPost Cataract With Residual Astigmatism
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
Natural AstigmatismPost Cataract With Residual Astigmatism
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/34 (2.9%) 1/6 (16.7%)
Surgical and medical procedures
Hospitalization for auto accident1/34 (2.9%) 11/6 (16.7%) 1
Other (Not Including Serious) Adverse Events
Natural AstigmatismPost Cataract With Residual Astigmatism
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/34 (2.9%) 1/6 (16.7%)
Eye disorders
Ocular Penetration1/34 (2.9%) 20/6 (0%) 0
Immune system disorders
Possible Allergy to Preservative in Ocular Medication0/34 (0%) 01/6 (16.7%) 1

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

All proposed submissions for publication or presentation of Trial data must be approved by the Sponsor prior to submission. Under no circumstances shall the Investigator(s) publish or disclose data without the Sponsor's written approval.

Results Point of Contact

Name/TitleCarrie Garufis
OrganizationAbbott Medical Optics
Phone714-247-8200
Emailcarrie.garufis@amo.abbott.com
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01348854
Other Study ID Numbers:
  • FMTO-103-ISAK
First Posted:
May 6, 2011
Last Update Posted:
Jun 4, 2014
Last Verified:
May 1, 2014