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

Not Applicable

Completed

• Conditions: Cataracts
• Interventions: Procedure: cataract surgery

• Registration Number: NCT01936740
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2012-10
• Study Completion: 2013-06
• Status Verified: 2013-09
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-05
• Last Update Submitted: 2013-09-05
• Study First Posted: 2013-09-06
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• bilateral age-related cataract
• good overall physical constitution
• LOCS 2-5

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HF easyTip 2.2mm	cataract surgery	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.
HF easyTip 2.8mm	cataract surgery	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.

Primary Outcome Measures

Name	Time	Method
phacoemulsification time	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	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)
fluid volume	intraoperative	amount of BSS used for dividing and conquering

Secondary Outcome Measures

Name	Time	Method
postoperative corneal oedema	1 day, 1 week, 6 months	central corneal thickness
postoperative endotheial cell loss	6 months

Trial Locations

Locations (1)

Department of Ophthalmology and Optometry of the Medical University Vienna; 🇦🇹 Vienna, Austria