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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01936727 |
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Date of registration:
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03/09/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of Two Phacoemulsification-methods: EasyTip 2.2mm vs. Infusion Assisted EasyTip 2.2mm
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Scientific title:
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Comparison of Two Phacoemulsification-methods: EasyTip 2.2mm vs. Infusion Assisted EasyTip 2.2mm |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01936727 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
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Phase:
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N/A
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Countries of recruitment
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Austria
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Contacts
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Name:
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Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Vienna |
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Key inclusion & exclusion criteria
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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)
Age minimum:
50 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cataracts
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Intervention(s)
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Procedure: cataract surgery
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Primary Outcome(s)
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fluid volume
[Time Frame: intraoperativ]
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phacoemulsification time
[Time Frame: intraoperative]
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effective phacoemulsification time
[Time Frame: intraoperativ]
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Secondary Outcome(s)
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postoperative corneal oedema
[Time Frame: 1 day, 1 week, 6 months]
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postoperative endotheial cell loss
[Time Frame: 6 months]
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Secondary ID(s)
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EK Nr:1053/2011
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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