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The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure including arcuate incisions (AI) correcting astigmatism, also referred to as arcuate keratotomy (AK). The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery and additionally perform arcuate keratotomy in individuals with more than 1.0 Diopter (dpt) of astigmatism. Cataract surgery will be performed in subjects who have signed an informed consent form.
Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: postoperative refraction, visual acuity, slitlamp examination, and corneal topography
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femtosecond Laser guided Arcuate Keratotomy | Experimental | Arcuate keratotomy will be performed together with Laser cataract surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femtosecond Laser guided Arcuate Keratotomy | Device | Astigmatism will be reduced in cataract surgery using a low energy Femtosecond Laser device |
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| Measure | Description | Time Frame |
|---|---|---|
| Corneal Astigmatism one year after the intervention | H0: no change in postoperative refraction astigmatism H1: change in postoperative refraction astigmatism | 1 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Precision and reproducibility of corneal cut depth | Corneal Incisions will be measured using an anterior segment SS-OCT | 1 year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Schwarzenbacher, MD | Contact | 0140400 | 79450 | luca.schwarzenbacher@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Prospective interventional case series
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