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Comparison of Two Phacoemulsification-methods: Low Fluidic EasyTip 2.2mm vs. High Fluidic EasyTip 2.2mm

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ClinicalTrials.gov Identifier: NCT01936714
Recruitment Status : Completed
First Posted : September 6, 2013
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Rupert Menapace, Medical University of Vienna

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cataracts Procedure: cataract surgery Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Comparison of Two Phacoemulsification-methods: Low Fluidic EasyTip 2.2mm vs. High Fluidic EasyTip 2.2mm
Study Start Date : February 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
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.
 Procedure: cataract surgery
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.
 Procedure: cataract surgery


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. effective phacoemulsification time [ Time Frame: intraoperative ]
    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)

  3. fluid volume [ Time Frame: intraoperative ]
    amount of BSS used for dividing and conquering


Secondary Outcome Measures :
  1. postoperative corneal oedema [ Time Frame: 1 day, 1 week, 6 months ]
    central corneal thickness

  2. postoperative endotheial cell loss [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936714


Locations
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Austria
Department of Ophthalmology and Optometry of the Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
More Information
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Responsible Party: Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01936714    
Other Study ID Numbers: EK Nr: 2007/2012
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015
Keywords provided by Rupert Menapace, Medical University of Vienna:
Efficacy and Safety
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases