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

NCT01936714 | Completed

• 1 other identifier: EK Nr: 2007/2012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataracts

Keywords

Efficacy and Safety

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• fluid volume

  amount of BSS used for dividing and conquering

  intraoperative

Secondary Outcomes (2)

• postoperative corneal oedema

  1 day, 1 week, 6 months

• postoperative endotheial cell loss

  6 months

Study Arms (2)

HF easyTip 2.2mm

OTHER

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

OTHER

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

Interventions

cataract surgery PROCEDURE

HF easyTip 2.2mm; LF easyTip 2.2mm

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Ophthalmology and Optometry of the Medical University Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ao.Univ.-Prof. Dr.med.univ.

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 6, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

AU (1)