Trial Outcomes & Findings for Feasibility of iFS™ for Intrastromal Arcuate Keratotomy (ISAK) Procedures (NCT NCT01210820)
NCT ID: NCT01210820
Last Updated: 2013-05-01
Results Overview
Change in mean cylinder (assessed by manifest refraction) compared to baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
6 months
Results posted on
2013-05-01
Participant Flow
Participants were recruited from an Ophthalmic medical clinic during the period of July 2010 to April 2011.
Participant milestones
| Measure |
Natural Astigmatism
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
|
Post Cataract With Residual Astigmatism
Subjects who have had cataract removal surgery but have residual astigmatism.
iFS™ Femtosecond Laser System : intrastromal arcuate cuts made with iFS™ femtosecond laser
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
4
|
|
Overall Study
COMPLETED
|
17
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of iFS™ for Intrastromal Arcuate Keratotomy (ISAK) Procedures
Baseline characteristics by cohort
| Measure |
Natural Astigmatism
n=17 Participants
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
|
Post Cataract With Residual Astigmatism
n=4 Participants
Subjects who have had cataract removal surgery but have residual astigmatism.
iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
66 years
STANDARD_DEVIATION 12.4 • n=99 Participants
|
61 years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
65 years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
17 participants
n=99 Participants
|
4 participants
n=107 Participants
|
21 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsChange in mean cylinder (assessed by manifest refraction) compared to baseline.
Outcome measures
| Measure |
Natural Astigmatism
n=17 Participants
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
|
Post Cataract With Residual Astigmatism
n=4 Participants
Subjects who have had cataract removal surgery but have residual astigmatism.
iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser
|
|---|---|---|
|
Change in Refractive Astigmatism
|
-0.97 Diopter of cylinder change
Standard Deviation 0.43
|
-0.81 Diopter of cylinder change
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: 6 MonthsChange in mean keratometric cylinder (as measured by keratometry) compared to baseline.
Outcome measures
| Measure |
Natural Astigmatism
n=17 Participants
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
|
Post Cataract With Residual Astigmatism
n=4 Participants
Subjects who have had cataract removal surgery but have residual astigmatism.
iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser
|
|---|---|---|
|
Change in Keratometric Cylinder
|
-0.81 Diopters of astigmatism change
Standard Deviation 0.62
|
-0.63 Diopters of astigmatism change
Standard Deviation 0.78
|
Adverse Events
Natural Astigmatism
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post Cataract With Residual Astigmatism
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER