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To determine if arcuate incisions performed with the iFS femtosecond laser are safe and effective in reducing corneal astigmatism.
Surgeons will perform arcuate incisions in the cornea in arc segment patterns using the iFS femtosecond laser to treat subjects with corneal astigmatism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natural Astigmatism | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iFS Femtosecond Laser System | Device | arcuate incisions placed with the iFS femtosecond laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Astigmatism | Reduction of astigmatism as determined by manifest refractive cylinder | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA) | 6 months |
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Inclusion Criteria:
Male or female, of any race, and at least 21 years of age at the time of pre-op exam
Corneal astigmatism, as determined by topographic keratometry, of 0.75 D to 4.00 diopters (D)
Best Spectacle Corrected Distance Visual Acuity (BSCVA)
Group 1:
Group 2:
Uncorrected Visual Acuity (UCVA) of 20/40 or worse
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.
Preoperative central pachymetry of >/=480 um
Keratometry between 38.0 D (flat) to 48.0 D (steep)
Corneal power (diopters) difference at the 3mm point from topographic center shall be \
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Tarantino, OD | Abbott Medical Optics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paracelsus Medizinische Privat-Universitat, PMU | Salzburg | State of Salzburg | A5020 | Austria | ||
| CHU Morvan |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Post Cataract With Residual Astigmatism |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction of Astigmatism | Reduction of astigmatism as determined by manifest refractive cylinder | 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. | Posted | Mean | Standard Deviation | diopter | 6 months | eyes | Participants |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for auto accident | Surgical and medical procedures | Systematic Assessment | Subject hospitalized after auto accident unrelated to study device or procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular Penetration | Eye disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carrie Garufis | Abbott Medical Optics | 714-247-8200 | carrie.garufis@amo.abbott.com |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Brest |
| Brest |
| 29609 |
| France |
| Bochum-Langendreer | Bochum | Bochum | 44892 | Germany |
| Potsdamer Augenklinik im | Potsdam | Potsdam | 14467 | Germany |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | paticipants |
|
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.
|
|
| Secondary | Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA) | 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. | Posted | Number | percentage of eyes | 6 months | eyes | Participants |
|
|
|
| 1 |
| 34 |
| 1 |
| 34 |
| EG001 | 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. | 1 | 6 | 1 | 6 |
|
| Possible Allergy to Preservative in Ocular Medication | Immune system disorders | Systematic Assessment | Subject demonstrated possible allergic response to standard postoperative eye drops which was eliminated by changing to a different type of eye drops. |
|
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.