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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01210820
Recruitment Status : Completed
First Posted : September 29, 2010
Results First Posted : April 26, 2013
Last Update Posted : May 1, 2013
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Refractive Astigmatism
Intervention Device: iFS™ Femtosecond Laser System
Enrollment 21
Recruitment Details Participants were recruited from an Ophthalmic medical clinic during the period of July 2010 to April 2011.
Pre-assignment Details  
Arm/Group Title Natural Astigmatism Post Cataract With Residual Astigmatism
Hide Arm/Group Description

Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.

iFS™ Femtosecond Laser System : intrastromal arcuate cuts made with iFS™ femtosecond laser

Subjects who have had cataract removal surgery but have residual astigmatism.

iFS™ Femtosecond Laser System : intrastromal arcuate cuts made with iFS™ femtosecond laser

Period Title: Overall Study
Started 17 4
Completed 17 4
Not Completed 0 0
Arm/Group Title Natural Astigmatism Post Cataract With Residual Astigmatism Total
Hide Arm/Group Description

Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.

iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser

Subjects who have had cataract removal surgery but have residual astigmatism.

iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser

Total of all reporting groups
Overall Number of Baseline Participants 17 4 21
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 4 participants 21 participants
66  (12.4) 61  (12.1) 65  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 4 participants 21 participants
Female
7
  41.2%
3
  75.0%
10
  47.6%
Male
10
  58.8%
1
  25.0%
11
  52.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Austria Number Analyzed 17 participants 4 participants 21 participants
17 4 21
1.Primary Outcome
Title Change in Refractive Astigmatism
Hide Description Change in mean cylinder (assessed by manifest refraction) compared to baseline.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Natural Astigmatism Post Cataract With Residual Astigmatism
Hide Arm/Group Description:

Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.

iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser

Subjects who have had cataract removal surgery but have residual astigmatism.

iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser

Overall Number of Participants Analyzed 17 4
Mean (Standard Deviation)
Unit of Measure: Diopter of cylinder change
-0.97  (0.43) -0.81  (0.35)
2.Primary Outcome
Title Change in Keratometric Cylinder
Hide Description Change in mean keratometric cylinder (as measured by keratometry) compared to baseline.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Natural Astigmatism Post Cataract With Residual Astigmatism
Hide Arm/Group Description:

Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.

iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser

Subjects who have had cataract removal surgery but have residual astigmatism.

iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser

Overall Number of Participants Analyzed 17 4
Mean (Standard Deviation)
Unit of Measure: Diopters of astigmatism change
-0.81  (0.62) -0.63  (0.78)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Natural Astigmatism Post Cataract With Residual Astigmatism
Hide Arm/Group Description

Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.

iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser

Subjects who have had cataract removal surgery but have residual astigmatism.

iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser

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 (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Natural Astigmatism Post Cataract With Residual Astigmatism
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/4 (0.00%) 
This evaluation was performed on a small number of subjects and should be repeated in a larger number of subjects.
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.
At least 1 month prior to any proposed submission for publication or presentation of Trial data or other findings related to the Trial, the Institution will provide the Sponsor with a manuscript for review, comment, and approval. Under no circumstances shall the Institution or PI publish or disclose the Sponsor's confidential Information without the Sponsor's prior written approval.The manner in which the publication will be generated will be negotiated between the Sponsor and PI.
Results Point of Contact
Name/Title: Carrie Garufis
Organization: AMO Development, LLC
Phone: 714-566-3728
Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01210820     History of Changes
Other Study ID Numbers: FMTO-102-ISAK
First Submitted: September 24, 2010
First Posted: September 29, 2010
Results First Submitted: January 22, 2013
Results First Posted: April 26, 2013
Last Update Posted: May 1, 2013