Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2013-12-31
2015-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Victus Group
The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
Victus
The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
Conventional Group
The Conventional Group acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually
Conventional Phaco
The capsulotomy as well as the lens fragmentation is performed manually.
Interventions
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Victus
The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
Conventional Phaco
The capsulotomy as well as the lens fragmentation is performed manually.
Eligibility Criteria
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Inclusion Criteria
* related cataract
* Ability to follow instructions from the treatment team
* Both eyes to receive surgery
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Technolas Perfect Vision GmbH
INDUSTRY
Matthias Bolz
OTHER
Responsible Party
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Matthias Bolz
MD
Principal Investigators
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Matthias Bolz, MD
Role: PRINCIPAL_INVESTIGATOR
AKh Linz, Ophthalmology
Locations
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AKh Linz
Linz, Upper Austria, Austria
Countries
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Central Contacts
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Other Identifiers
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13A06
Identifier Type: -
Identifier Source: org_study_id
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