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

Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936714
• Other study ID #: EK Nr: 2007/2012
• Status: Completed
• Phase: N/A
• First received: September 3, 2013
• Last updated: April 9, 2015
• Start date: February 2013
• Est. completion date: September 2013

Study information

• Verified date: April 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionAustria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Cataracts

Intervention

Procedure:
• cataract surgery

Locations

Country	Name	City	State
Austria	Department of Ophthalmology and Optometry of the Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	phacoemulsification time	time spent for the phacoemulsification process was the phacoemulsification tip time (PTT) needed to divide the nucleus and the PTT needed to conquer it	intraoperative	No
Primary	effective phacoemulsification time	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)	intraoperative	No
Primary	fluid volume	amount of BSS used for dividing and conquering	intraoperative	No
Secondary	postoperative corneal oedema	central corneal thickness	1 day, 1 week, 6 months	No
Secondary	postoperative endotheial cell loss		6 months	No