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

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

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

Conditions
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Cataracts

Intervention / Treatment
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* Procedure: cataract surgery


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HF easyTip 2.2mm<br>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<br> <br> |
| Other: LF easyTip 2.2mm<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative corneal oedema | central corneal thickness | 1 day, 1 week, 6 months | 
| postoperative endotheial cell loss |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy and Safety