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| Name | Class |
|---|---|
| Technolas Perfect Vision GmbH | INDUSTRY |
Cataract surgery is among the world's most frequently performed operations. It involves removal of an opaque lens from the human eye and implantation of an artificial lens. The operation is performed under local anaesthesia using ultrasound technology, by which the lens is emulsified and removed by suction.
Femtosecond laser-assisted cataract surgery is a new innovative surgical procedure that can improve the quality of cataract surgery and provide a new best possible standard of quality. In contrast to the conventional method the capsulotomy and the fragemntation are fully automatically performed with a femtosecond laser. In addition, the lens is fragmented by the laser, which substantially facilitates its removal and reduces the operation time.
Study to investigate whether the femtosecond laser cataract surgery causes any significant differences in clinical outcomes as compared to the conventional, manual continuous curvilinear capsulorhexis (CCC).
Effective phako time (EPT) is defined as duration of phakoemulsifikation of the crystalline lens.
EPT of conventional surgery at intraoperative visit > EPT oflaser-assisted surgery at intraoperative visit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Victus Group | Experimental | The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery |
|
| Conventional Group | Other | The Conventional Group acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Victus | Device | The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effective Phaco Time | EPT of the conventional cataract surgery (mesured intraoperativ = Visit 2) is smaller or equal to the EPT of the Laser-assisted cataract surgery (meausred intraoperativ = Visit 2) | surgery day |
| Measure | Description | Time Frame |
|---|---|---|
| IOL overlap | The difference in the IOL overlap between group A and B. The IOL overlap, ΔROverlap, is the euclidian distance between the center of mass of the capsulotomy and the center of mass of the IOL, representing the symmetry of the IOL-Capsulotomy aperture- overlap | 1 month, 3 and 6 months |
| IOL Centration |
| Measure | Description | Time Frame |
|---|---|---|
| patients subjective perception | Patients' subjective perceptions of the two operative procedures | 1 day |
| cornea, retina | Effects of the surgical techniques on the cornea and retina as assessed by optical coherence tomography, endothelial cell count or Pentacam. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthias Bolz, MD | Contact | +43 (0)732 7806 | 1310 | Matthias.Bolz@akh.linz.at |
| Martin Dirisamer | Contact | +43 (0)732 7806 | 1310 | martin.dirisamer@akh.linz.at |
| Name | Affiliation | Role |
|---|---|---|
| Matthias Bolz, MD | AKh Linz, Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKh Linz | Recruiting | Linz | Upper Austria | 4021 | Austria |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Conventional Phaco | Device | The capsulotomy as well as the lens fragmentation is performed manually. |
|
The difference in the IOL centration between group A and B. The IOL centration is the euclidian distance between the center of mass of the IOL and the center of mass of the dilated pupil |
| 1 month, 3 and 6 months |
| 1 month, 3 and 6 month |