NCT01991717

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

1.1 years

First QC Date

November 18, 2013

Last Update Submit

January 20, 2014

Conditions

Cataract

Keywords

Victuslensfragmentationfemtosecond laser assistedcapsulotomy,manual, continuous curvilinear capsulorhexis (CCC)effective phaco time, phaco

Outcome Measures

Primary Outcomes (1)

  • 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)

    surgery day

Secondary Outcomes (2)

  • IOL overlap

    1 month, 3 and 6 months

  • IOL Centration

    1 month, 3 and 6 months

Other Outcomes (2)

  • patients subjective perception

    1 day

  • cornea, retina

    1 month, 3 and 6 month

Study Arms (2)

Victus Group

EXPERIMENTAL

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

Device: Victus

Conventional Group

OTHER

The Conventional Group acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually

Device: Conventional Phaco

Interventions

VictusDEVICE

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

Victus Group
Conventional PhacoDEVICE

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

Conventional Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years
  • related cataract
  • Ability to follow instructions from the treatment team
  • Both eyes to receive surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AKh Linz

Linz, Upper Austria, 4021, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Matthias Bolz, MD

    AKh Linz, Ophthalmology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Bolz, MD

CONTACT

+43 (0)732 7806Matthias.Bolz@akh.linz.at

Martin Dirisamer

CONTACT

+43 (0)732 7806martin.dirisamer@akh.linz.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 25, 2013

Study Start

December 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

AU(1)