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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01936740

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Official Title:

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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.	Procedure: cataract surgery

Arm

Intervention/Treatment

Other: 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

Other: 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.

Procedure: cataract surgery

Outcome Measures

Primary Outcome Measures

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

postoperative corneal oedema [1 day, 1 week, 6 months]
central corneal thickness
postoperative endotheial cell loss [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology and Optometry of the Medical University Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ., Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT01936740

Other Study ID Numbers:

Ek Nr: 1268/2012

First Posted:

Sep 6, 2013

Last Update Posted:

Sep 6, 2013

Last Verified:

Sep 1, 2013

Keywords provided by Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ., Medical University of Vienna

Efficacy and Safety

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Sep 6, 2013