CataractNCT01991717
Victus Versus Conventional
A study testing Victus and Conventional Phaco in people with Cataract, run by Matthias Bolz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Victus and Conventional Phaco
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years
- related cataract
- Ability to follow instructions from the treatment team
- Both eyes to receive surgery
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Investigator-masked Study Comparing Femtosecond Laser Assisted With Conventional Phacoemulsification Cataract Surgery
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.
Read more
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
- Conditions
- Cataract
- Being tested
- Victus, Conventional Phaco
- Keywords
- Victus, lensfragmentation, femtosecond laser assisted, capsulotomy,, manual, continuous curvilinear capsulorhexis (CCC), effective phaco time, phaco
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VictusDevice
The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
Conventional PhacoDevice
The capsulotomy as well as the lens fragmentation is performed manually.
| Study group | Role | What they receive |
|---|---|---|
| Victus Group | Experimental | The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery Receives: 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 Receives: Device: Conventional Phaco |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: surgery day
Secondary outcomes (2)
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
Measured: 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
Measured: 1 month, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthias Bolz
- Sponsor type
- University, hospital or other
- Collaborators
- Technolas Perfect Vision GmbH
- Responsible party
- Sponsor-investigator, Matthias Bolz, Augenabteilung Allgemeines Krankenhaus Linz
- Investigators
- Matthias Bolz, MD, Principal investigator, AKh Linz, Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991717
- Sponsor's protocol ID
- 13A06
- Status last verified
- Jan 2014
- First submitted
- 18 Nov 2013
- Last updated
- 22 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Investigator-masked Study Comparing Femtosecond Laser Assisted With Conventional Phacoemulsification Cataract Surgery
- ClinicalTrials.gov ID
- NCT01991717
- Acronym / sponsor ID
- 13A06
- Conditions
- Cataract
- Keywords
- Victus, lensfragmentation, femtosecond laser assisted, capsulotomy,, manual, continuous curvilinear capsulorhexis (CCC), effective phaco time, phaco
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Matthias BolzUniversity, hospital or other
- Collaborators
- Technolas Perfect Vision GmbH
- Study start
- Dec 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Victus Group | Experimental | Device: VictusThe anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery |
| Conventional Group | Other | Device: Conventional PhacoThe Conventional Group acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years
- related cataract
- Ability to follow instructions from the treatment team
- Both eyes to receive surgery
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VictusThe anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery | Device | Victus Group |
| Conventional PhacoThe capsulotomy as well as the lens fragmentation is performed manually. | Device | Conventional Group |
Primary outcome
Effective Phaco Time
Time frame: surgery day
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)
2 secondary outcomes
IOL overlap
Time frame: 1 month, 3 and 6 months
IOL Centration
Time frame: 1 month, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Bolz, MD principal investigator
AKh Linz, Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Victus and Conventional Phaco in people with Cataract, run by Matthias Bolz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Bolz, MD (+43 (0)732 7806 ext. 1310, Matthias.Bolz@akh.linz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Phaco Time (time frame: surgery day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.