Intra-Operative Metrics With CENTURION® and INFINITI® Vision Systems
- Conditions
- Cataract
- Registration Number
- NCT01848288
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to evaluate intra-operative phacoemulsification machine metrics after phacoemulsification with the CENTURION® vision system configuration compared with the INFINITI® vision system configuration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- Eligible to undergo cataract extraction via phacoemulsification with primary ACRYSOF Intraocular Lens (IOL) implantation;
- Free of severe disease(s)/condition(s) listed in the "Warnings" and "Precautions" section of implanted ACRYSOF IOL;
- Willing to undergo second eye surgery within 14 days of first eye surgery;
- Willing and able to understand/sign a written Informed Consent Document;
- Willing and able to return for scheduled follow-up examinations;
- Other protocol-defined inclusion criteria may apply.
- Planned multiple procedures at the time of surgery or during the course of the study (eg, LASIK, LRI, etc.);
- Previous intraocular or corneal surgery of any kind;
- Poorly dilating pupil;
- Severe retinal disorders (eg, macular degeneration, proliferative diabetic retinopathy);
- Corneal disease (eg, herpes simplex, herpes zoster, etc) or retinal detachment;
- Severe conditions that per Investigator's clinical judgment would increase the operative risk or confound the result of this investigation;
- Female patients who are pregnant, lactating, or planning to be pregnant during the course of the study;
- Currently participating in another drug or device clinical trial, or participated in another drug or device clinical trial within 30 days of enrollment into this trial;
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Cumulative Dissipated Energy Day 0 (operative day), each eye Cumulative Dissipated Energy (CDE) is an estimation of the energy at the incision site experienced during the removal of cataractous lens and is measured in %-secs. The incision is defined as 5.6mm back from the cutting edge of the tip. A lower CDE indicates that less energy was present at the incision site.
Aspiration (ASP) Fluid Used Day 0 (operative day), each eye Aspiration fluid used is the amount of aspiration fluid used during the removal of the cataractous lens. A lower value indicates that less fluid was removed from the eye.
- Secondary Outcome Measures
Name Time Method Aspiration Time Day 0 (operative day), each eye Aspiration Time indicated the amount of time the system was aspirating during the removal of the cataractous lens. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery.
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