Victus Versus Conventional

N/AUnknownNCT01991717

Matthias Bolz50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cataract

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: surgery day

Secondary Outcomes

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

Time frame: 1 month, 3 and 6 months

IOL Centration

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