Prospective Evaluation of the Long-term Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Evaluation of the Long-term (18 Months) Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions Following Cataract Surgery

Conditions
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Astigmatism

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clear corneal media Patients must be at least 40 years of age VICTUS™ femtosecond laser-assisted arcuate incisions surgery Preoperative Keratometric astigmatism: ≥ 1.0D and ≤ 3D Patients must have read, understood the Patient Information and signed the informed consent form Patients are willing and able to return for follow-up examinations Exclusion Criteria: Corneal disease or pathology, such as corneal scaring Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc. Manifest Glaucoma Known sensitivity to planned concomitant medications Patients regularly taking medicines that could influence the result of the treatment respectively the vision Patients with disorders of the ocular muscle, such as nystagmus or strabismus Patients with keratoconus, keratectasia or other irregular cornea changes Patients with connective tissue weakness Subjects who are immune compromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis, collagenosis and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study. Abnormal examination results from slit lamp, fundus examination or IOLMaster; age related changes are acceptable Patients with eye diseases which decreases the visual acuity such as macular degeneration, macular edema, proliferative diabetic retinopathy Abnormal examination results from topography, age related changes are acceptable Patients who are pregnant or nursing Patients with concentration disorders, epilepsy and other complicating diseases Patients who are participating in another clinical study 30 days before

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | Postoperative Objective Astigmatism (manifest refraction) ≤ 1.0 D in 60% of eyes | 18 months after VICTUS femtosecond laser-assisted arcuate incisions treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Astigmatism, arcuate incisions, astigmatic keratotomy