Victus Versus Conventional

NCT ID: NCT01991717

Last Updated: 2014-01-22

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Victus Group

The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery

Group Type EXPERIMENTAL

Victus

Intervention Type DEVICE

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

Group Type OTHER

Conventional Phaco

Intervention Type DEVICE

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

Intervention Type DEVICE

Conventional Phaco

The capsulotomy as well as the lens fragmentation is performed manually.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technolas Perfect Vision GmbH

INDUSTRY

Sponsor Role collaborator

Matthias Bolz

OTHER

Sponsor Role lead

Responsible Party

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Matthias Bolz

MD

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Matthias Bolz, MD

Role: CONTACT

+43 (0)732 7806 ext. 1310

Martin Dirisamer

Role: CONTACT

+43 (0)732 7806 ext. 1310

Other Identifiers

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13A06

Identifier Type: -

Identifier Source: org_study_id

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