Trial Outcomes & Findings for Safety and Effectiveness of Arcuate Incisions Performed With the iFS Femtosecond Laser System (NCT NCT01348854)
NCT ID: NCT01348854
Last Updated: 2014-06-04
Results Overview
Reduction of astigmatism as determined by manifest refractive cylinder
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
6 months
Results posted on
2014-06-04
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
6
|
|
Overall Study
COMPLETED
|
31
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Safety and Effectiveness of Arcuate Incisions Performed With the iFS Femtosecond Laser System
Baseline characteristics by cohort
| Measure |
Natural Astigmatism
n=34 Participants
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.
|
Post Cataract With Residual Astigmatism
n=6 Participants
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
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 15.9 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
0 paticipants
n=5 Participants
|
1 paticipants
n=7 Participants
|
1 paticipants
n=5 Participants
|
|
Region of Enrollment
Austria
|
17 paticipants
n=5 Participants
|
2 paticipants
n=7 Participants
|
19 paticipants
n=5 Participants
|
|
Region of Enrollment
Germany
|
17 paticipants
n=5 Participants
|
3 paticipants
n=7 Participants
|
20 paticipants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
Reduction of astigmatism as determined by manifest refractive cylinder
Outcome measures
| Measure |
Natural Astigmatism
n=49 eyes
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.
|
Post Cataract With Residual Astigmatism
n=6 eyes
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.
|
|---|---|---|
|
Reduction of Astigmatism
|
-0.75 diopter
Standard Deviation 0.94
|
-0.88 diopter
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Outcome measures
| Measure |
Natural Astigmatism
n=51 eyes
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.
|
Post Cataract With Residual Astigmatism
n=10 eyes
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.
|
|---|---|---|
|
Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)
|
4.9 percentage of eyes
|
0 percentage of eyes
|
Adverse Events
Natural Astigmatism
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Post Cataract With Residual Astigmatism
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Natural Astigmatism
n=34 participants at risk
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.
|
Post Cataract With Residual Astigmatism
n=6 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Hospitalization for auto accident
|
2.9%
1/34 • Number of events 1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Natural Astigmatism
n=34 participants at risk
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.
|
Post Cataract With Residual Astigmatism
n=6 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Ocular Penetration
|
2.9%
1/34 • Number of events 2 • 1 year
|
0.00%
0/6 • 1 year
|
|
Immune system disorders
Possible Allergy to Preservative in Ocular Medication
|
0.00%
0/34 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER