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

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ClinicalTrials.gov Identifier: NCT01348854
Recruitment Status : Completed
First Posted : May 6, 2011
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Corneal Astigmatism
Intervention Device: iFS Femtosecond Laser System
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Natural Astigmatism Post Cataract With Residual Astigmatism
Hide Arm/Group Description 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. 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
Started 34 [1] 6 [2]
Completed 31 [3] 5 [4]
Not Completed 3 1
Reason Not Completed
Lost to Follow-up             2             1
Withdrawal by Subject             1             0
[1]
53 eyes of 34 participants
[2]
10 eyes of 6 participants
[3]
47 eyes of 31 participants
[4]
9 eyes of 5 participants
Arm/Group Title Natural Astigmatism Post Cataract With Residual Astigmatism Total
Hide Arm/Group Description 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. 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 Number of Baseline Participants 34 6 40
Hide Baseline 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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 6 participants 40 participants
52.4  (16.6) 55.0  (15.9) 53.7  (16.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 6 participants 40 participants
Female
26
  76.5%
5
  83.3%
31
  77.5%
Male
8
  23.5%
1
  16.7%
9
  22.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Paticipants
Number Analyzed 34 participants 6 participants 40 participants
France 0 1 1
Austria 17 2 19
Germany 17 3 20
1.Primary Outcome
Title Reduction of Astigmatism
Hide Description Reduction of astigmatism as determined by manifest refractive cylinder
Time Frame 6 months
Hide Outcome Measure Data
Hide 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 Title Natural Astigmatism Post Cataract With Residual Astigmatism
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 32 4
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
49 6
Mean (Standard Deviation)
Unit of Measure: diopter
-0.75  (0.94) -0.88  (0.26)
2.Secondary Outcome
Title Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide 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 Title Natural Astigmatism Post Cataract With Residual Astigmatism
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 33 6
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
51 10
Measure Type: Number
Unit of Measure: percentage of eyes
4.9 0
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Natural Astigmatism Post Cataract With Residual Astigmatism
Hide Arm/Group Description 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. 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 Astigmatism Post Cataract With Residual Astigmatism
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Natural Astigmatism Post Cataract With Residual Astigmatism
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/34 (2.94%)      1/6 (16.67%)    
Surgical and medical procedures     
Hospitalization for auto accident  [1]  1/34 (2.94%)  1 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
[1]
Subject hospitalized after auto accident unrelated to study device or procedure.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Natural Astigmatism Post Cataract With Residual Astigmatism
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/34 (2.94%)      1/6 (16.67%)    
Eye disorders     
Ocular Penetration   1/34 (2.94%)  2 0/6 (0.00%)  0
Immune system disorders     
Possible Allergy to Preservative in Ocular Medication  [1]  0/34 (0.00%)  0 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
[1]
Subject demonstrated possible allergic response to standard postoperative eye drops which was eliminated by changing to a different type of eye drops.

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.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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/Title: Carrie Garufis
Organization: Abbott Medical Optics
Phone: 714-247-8200
Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01348854     History of Changes
Other Study ID Numbers: FMTO-103-ISAK
First Submitted: May 4, 2011
First Posted: May 6, 2011
Results First Submitted: January 31, 2014
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014