Cataract
Conditions
Keywords
Victus, lensfragmentation, femtosecond laser assisted, capsulotomy,, manual, continuous curvilinear capsulorhexis (CCC), effective phaco time, phaco
Brief summary
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
Interventions
DEVICEVictus
The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
DEVICEConventional Phaco
The capsulotomy as well as the lens fragmentation is performed manually.
Sponsors
Technolas Perfect Vision GmbH
Matthias Bolz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years * related cataract * Ability to follow instructions from the treatment team * Both eyes to receive surgery
Exclusion criteria
* Narrow pupils (in ther. mydriasis \<6mm) * Narrow orbits * Sunken eyes * manifest glaucoma treated with anti-glaucomatous therapy or prior surgery * Conditions that pose a high risk of complications during surgery * Known sensitivity to planned concomitant medications * Patients with disorders of the ocular muscle, such as nystagmus or strabismus * Patients who are blind on one eye * Acute or chronic systemic and/or ocular illnesses that are clinically significant and will increase the risk to the subject or confound the outcomes of this study, such as but not restricted to diabetes mellitus, autoimmune/rheumatic or connective tissue diseases, dementia or epilepsy. * Patients who are pregnant or nursing * Patients who do not give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective Phaco Time | surgery day | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOL overlap | 1 month, 3 and 6 months | 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 |
| IOL Centration | 1 month, 3 and 6 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| patients subjective perception | 1 day | Patients' subjective perceptions of the two operative procedures |
| cornea, retina | 1 month, 3 and 6 month | Effects of the surgical techniques on the cornea and retina as assessed by optical coherence tomography, endothelial cell count or Pentacam. |
Countries
Austria
Contacts
Primary ContactMatthias Bolz, MD
Backup ContactMartin Dirisamer
Outcome results
None listed