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This clinical phase IV study is an open, prospective phase IV study and acts to evaluate the effectiveness of the femtolaser-assisted astigmatic keratotomy.
The purpose of this prospective phase IV study acts to address the predictability and effectiveness of astigmatic keratotomy in eyes after femtolaser-assisted cataract surgery. Within this prospective data collection the laser-assisted Arcuate Incisions are performed by the VICTUS™ Femtosecond Laser Platform.
This study will be conducted at Gemini eye clinic in Zlin, Czech Republic by Dr. Pavel Stodulka who will treat up to 50 eyes. Patients will be recruited according to the study inclusion/exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Astigmatic keratotomy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser-assisted Astigmatic keratotomy | Device | Laser-assisted Astigmatic keratotomy are performed by the VICTUS™ Femtosecond Laser Platform. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Keratomic corneal astigmatism | The postoperative keratomic corneal astigmatism is in 60% of all eyes equal or better than 1.0D | The study endpoints will be calculated for the 3-Months follow-up examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Topographic corneal and subjective cylinder |
| This end point is measured at the 3 Months Follow Up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pavel Stodulka, Dr. med | Gemini clinic, Zlin | Principal Investigator |
| Pavel Stodulka, Dr. med | Gemini Eye Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemini Eye Clinic | Zlín | 76001 | Czechia |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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