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OpenTrials
Completed

NCT Number: NCT01936727

Comparison of Two Phacoemulsification-methods: EasyTip 2.2mm vs. Infusion Assisted EasyTip 2.2mm

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

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology and Optometry of the Medical University Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

cataract surgery

Procedure

Primary outcomes

  1. phacoemulsification time

    Time frame: 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

  2. effective phacoemulsification time

    Time frame: intraoperativ

    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)

  3. fluid volume

    Time frame: intraoperativ

    amount of BSS used for dividing and conquering

Secondary outcomes

  1. postoperative corneal oedema

    Time frame: 1 day, 1 week, 6 months

    central corneal thickness

  2. postoperative endotheial cell loss

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 6, 2013
Registry last updated
Sep 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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