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This clinical study is an open, controlled, prospective, single center, single-surgeon, post-market-clinical-follow-up study to evaluate the long-term (18 months) effectiveness of the femtolaser-assisted astigmatic keratotomy.
The purpose of this prospective post-market-clinical-follow-up study is to address the long-term effectiveness of arcuate incisions, in eyes after VICTUS femtosecond laser-assisted astigmatic keratotomy.
This study will be conducted at Gemini eye clinic in Zlin, Czech Republic by Dr. Pavel Stodulka who will examine up to 100 eyes who previously received VICTUS femtolaser-assisted arcuate incisions treatment.
Patients will be recruited according to the study inclusion/exclusion criteria.
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative keratometric cylinder | Postoperative Astigmatism (keratometry) ≤ 1.0 D in 60% of eyes | 18 months after the VICTUS femtosecond laser-assisted arcuate incisions. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Manifest Cylinder | Postoperative Manifest Astigmatism (manifest refraction) ≤ 1.0 D in 60% of eyes | 19 months after VICTUS femtosecond laser-assisted arcuate incisions treatment. |
| Postoperative Objective Cylinder |
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Inclusion Criteria:
Exclusion Criteria:
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Only the patients who were previously treated with VICTUS™ femtosecond laser-assisted arcuate incisions and successfully pass the eligibility criteria are eligible for this follow-up extension study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pavel Stodulka, Dr. med, PhD | Contact | +420734575158 | barinkova@gemini.cz |
| Name | Affiliation | Role |
|---|---|---|
| Pavel Stodulka, Dr. med, PhD | Gemini clinic, Zlin Pavel Stodulka, Dr. med Study Principal Investigator Gemini eye clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemini Eye Clinic | Recruiting | Zlín | 76001 | Czechia |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Postoperative Objective Astigmatism (manifest refraction) ≤ 1.0 D in 60% of eyes
| 18 months after VICTUS femtosecond laser-assisted arcuate incisions treatment. |