Comparison of Two Phacoemulsification-methods: EasyTip 2.2mm vs. Infusion Assisted EasyTip 2.2mm
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- phacoemulsification time
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •bilateral age-related cataract
- •good overall physical constitution
Exclusion Criteria
- •previous intraocular surgery or ocular trauma
- •previous corneal pathology
- •previous endothelial cell count \<1200
- •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)
Outcomes
Primary Outcomes
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
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)
fluid volume
Time Frame: intraoperativ
amount of BSS used for dividing and conquering
Secondary Outcomes
- postoperative corneal oedema(1 day, 1 week, 6 months)
- postoperative endotheial cell loss(6 months)
Investigators
Rupert Menapace
Ao.Univ.-Prof. Dr.med.univ.
Medical University of Vienna