CataractsNCT01936727
Comparison of Two Phacoemulsification-methods: EasyTip 2.2mm vs. Infusion Assisted EasyTip 2.2mm
A study testing cataract surgery in people with Cataracts, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this study was to compare the intraoperative efficiency, safety and postoperative outcomes of cataract surgery with two different "high-fluidic" settings. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cataracts
- What is being tested?
- cataract surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2011to Aug 2012
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral age-related cataract
- good overall physical constitution
- LOCS 2-5
Who cannot join
- previous intraocular surgery or ocular trauma
- previous corneal pathology
- previous endothelial cell count <1200
- glaucoma
- uveitis
- PEX
Show all 9Show fewer
- diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
- intraocular complication like posterior capsular
- postoperative comlpications (e.g. postoperative uveitis)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Ophthalmology and Optometry of the Medical University Vienna
Vienna, State of Vienna, 1090
About this study
The aim of this study was to compare the intraoperative efficiency, safety and postoperative outcomes of cataract surgery with two different "high-fluidic" settings.
- Conditions
- Cataracts
- Being tested
- cataract surgery
- Keywords
- efficiency and safety
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| HF easyTip 2.2mm | Other | The phacoemulsifications tip used was the easyTip 2.2mm tip (Oertli Instruments, Berneck, Switzerland). The cristaline lens was divided into four quadrants using an aspiration flow rate of 10ml/min and vacuum of 70 mmHg. The quadrants were aspirated using the following linear power and fluidic settings: aspiration flow rate 50ml/min, vacuum 600 mmHg, bottle height 100cm. Receives: Procedure: cataract surgery |
| infusion asissted easyTip | Other | The phacoemulsifications tip used was an infusion assisted easyTip 2.2mm (Oertli Instruments, Berneck, Switzerland). The cristaline lens was divided into four quadrants using an aspiration flow rate of 10ml/min and vacuum of 70 mmHg. The quadrants were aspirated using the following linear power and fluidic settings: aspiration flow rate 50ml/min, vacuum 600 mmHg, bottle height 100cm. Receives: Procedure: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
phacoemulsification time
time spent for the phacoemulsification process was the phacoemulsification tip time (PTT) needed to divide the nucleus and the PTT needed to conquer it
Measured: intraoperative
effective phacoemulsification time
time in seconds required had 100% power been used throughout the phacoemulsification process documented for the separation of the nucleus (divide) and the aspiration of the quadrants (conquer)
Measured: intraoperativ
fluid volume
amount of BSS used for dividing and conquering
Measured: intraoperativ
Secondary outcomes (2)
postoperative corneal oedema
central corneal thickness
Measured: 1 day, 1 week, 6 months
postoperative endotheial cell loss
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startDec 2011
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Menapace, Medical University of Vienna
- Investigators
- Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936727
- Sponsor's protocol ID
- EK Nr:1053/2011
- Status last verified
- Sep 2013
- First submitted
- 3 Sep 2013
- Last updated
- 6 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Phacoemulsification-methods: EasyTip 2.2mm vs. Infusion Assisted EasyTip 2.2mm
- ClinicalTrials.gov ID
- NCT01936727
- Acronym / sponsor ID
- EK Nr:1053/2011
- Conditions
- Cataracts
- Keywords
- efficiency and safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Sep 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.
The aim of this study was to compare the intraoperative efficiency, safety and postoperative outcomes of cataract surgery with two different "high-fluidic" settings.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HF easyTip 2.2mm | Other | Procedure: cataract surgeryThe phacoemulsifications tip used was the easyTip 2.2mm tip (Oertli Instruments, Berneck, Switzerland). The cristaline lens was divided into four quadrants using an aspiration flow rate of 10ml/min and vacuum of 70 mmHg. The quadrants were aspirated using the following linear power and fluidic settings: aspiration flow rate 50ml/min, vacuum 600 mmHg, bottle height 100cm. |
| infusion asissted easyTip | Other | Procedure: cataract surgeryThe phacoemulsifications tip used was an infusion assisted easyTip 2.2mm (Oertli Instruments, Berneck, Switzerland). The cristaline lens was divided into four quadrants using an aspiration flow rate of 10ml/min and vacuum of 70 mmHg. The quadrants were aspirated using the following linear power and fluidic settings: aspiration flow rate 50ml/min, vacuum 600 mmHg, bottle height 100cm. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- bilateral age-related cataract
- good overall physical constitution
- LOCS 2-5
Key exclusion criteria (9 listed)
- previous intraocular surgery or ocular trauma
- previous corneal pathology
- previous endothelial cell count <1200
- glaucoma
- uveitis
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 |
|---|---|---|
| cataract surgery | Procedure or surgery | HF easyTip 2.2mm, infusion asissted easyTip |
Primary outcome
phacoemulsification time
Time frame: intraoperative
time spent for the phacoemulsification process was the phacoemulsification tip time (PTT) needed to divide the nucleus and the PTT needed to conquer it
effective phacoemulsification time
Time frame: intraoperativ
time in seconds required had 100% power been used throughout the phacoemulsification process documented for the separation of the nucleus (divide) and the aspiration of the quadrants (conquer)
fluid volume
Time frame: intraoperativ
amount of BSS used for dividing and conquering
2 secondary outcomes
postoperative corneal oedema
Time frame: 1 day, 1 week, 6 months
postoperative endotheial cell loss
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
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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.
Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery in people with Cataracts, run by Medical University of Vienna 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 6 Sep 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phacoemulsification time (time frame: intraoperative). The study lists 3 primary outcomes in all. 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 6 Sep 2013; AzTrials last refreshed its copy on 29 Oct 2026.