Clinical trial NCT01991717: Victus Versus Conventional
Official title: An Open-label Investigator-masked Study Comparing Femtosecond Laser Assisted With Conventional Phacoemulsification Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Keywords: Victus
lensfragmentation
femtosecond laser assisted
capsulotomy,
manual, continuous curvilinear capsulorhexis (CCC)
effective phaco time, phaco
Lead sponsor: Augenabteilung Allgemeines Krankenhaus Linz
Sponsor class: OTHER
Collaborators: name: Technolas Perfect Vision GmbH
First posted: 2013-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Effective Phaco Time
timeFrame: surgery day
Secondary outcomes:
measure: IOL overlap
timeFrame: 1 month, 3 and 6 months
measure: IOL Centration
timeFrame: 1 month, 3 and 6 months
Other outcomes:
measure: patients subjective perception
timeFrame: 1 day
measure: cornea, retina
timeFrame: 1 month, 3 and 6 month
Locations:
city: Linz
country: Austria
facility: AKh Linz
state: Oberösterreich
Study officials:
affiliation: AKh Linz, Ophthalmology
name: Matthias Bolz, MD
role: PRINCIPAL_INVESTIGATOR
References: