Comparison of Two Phacoemulsification-methods: HF EasyTip 2.2mm vs. HF EasyTip 2.8mm

NCT ID: NCT01936740

Last Updated: 2013-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-06-30

Brief Summary

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The aim of this study was to compare the intraoperative efficiency, safety and postoperative outcomes of cataract surgery with two different "high-fluidic" settings.

Detailed Description

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Conditions

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Cataracts

Keywords

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Efficacy and Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type OTHER

cataract surgery

Intervention Type PROCEDURE

HF easyTip 2.8mm

The phacoemulsifications tip used was the easyTip 2.8mm 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.

Group Type OTHER

cataract surgery

Intervention Type PROCEDURE

Interventions

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cataract surgery

Intervention Type PROCEDURE

Eligibility 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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Rupert Menapace

Ao.Univ.-Prof. Dr.med.univ.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Ophthalmology and Optometry of the Medical University Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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Ek Nr: 1268/2012

Identifier Type: -

Identifier Source: org_study_id