- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01936714
Comparison of Two Phacoemulsification-methods: Low Fluidic EasyTip 2.2mm vs. High Fluidic EasyTip 2.2mm
April 9, 2015 updated by: Rupert Menapace, Medical University of Vienna
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 Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, 1090
- Department of Ophthalmology and Optometry of the Medical University Vienna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- bilateral age-related cataract
- good overall physical constitution
- LOCS 2-5
Exclusion Criteria:
- previous intraocular surgery or ocular trauma
- previous corneal pathology
- previous endothelial cell count <1200
- glaucoma
- uveitis
- PEX
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: HF easyTip 2.2mm
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 45ml/min, vacuum 600 mmHg, bottle height 100cm.
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Other: LF easyTip 2.2mm
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 20ml/min, vacuum 400 mmHg, bottle height 100cm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
phacoemulsification time
Time Frame: intraoperative
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time spent for the phacoemulsification process was the phacoemulsification tip time (PTT) needed to divide the nucleus and the PTT needed to conquer it
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intraoperative
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effective phacoemulsification time
Time Frame: intraoperative
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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)
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intraoperative
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fluid volume
Time Frame: intraoperative
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amount of BSS used for dividing and conquering
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intraoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative corneal oedema
Time Frame: 1 day, 1 week, 6 months
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central corneal thickness
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1 day, 1 week, 6 months
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postoperative endotheial cell loss
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
September 3, 2013
First Submitted That Met QC Criteria
September 5, 2013
First Posted (Estimate)
September 6, 2013
Study Record Updates
Last Update Posted (Estimate)
April 10, 2015
Last Update Submitted That Met QC Criteria
April 9, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK Nr: 2007/2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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