N/A
N=100
Intra-Operative Metrics With CENTURION® and INFINITI® Vision Systems
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT01848288 ↗Enrolled (actual)
100
Serious AEs
2.0%
Results posted
Mar 2015
Primary outcome: Primary: Cumulative Dissipated Energy — 4.32; 7.11 percent-seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CENTURION® Vision System (CVS) (Device); INFINITI® Vision System (IVS) (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Dissipated Energy |
4.32; 7.11 | — |
| PRIMARY Aspiration (ASP) Fluid Used |
46.56; 52.68 | — |
| SECONDARY Aspiration Time |
151.85; 167.63 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01848288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.