Advanced Vision Care
Los Angeles, California, 90067, United States
Location status: Recruiting
NCT Number: NCT07468877
This clinical trial compares two phacoemulsification systems used in a bilateral cataract surgery subjects, in order to study CDE and Ultrasound time during cataract removal
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Los Angeles, California, 90067, United States
Location status: Recruiting
Unity and Centurion are two phacoemulsification systems routinely used during cataract surgery to assist the surgeon in removing the cataractous lens from the eye. This clinical trial aims to compare the performance of Unity versus Centurion during standard cataract surgery.
The primary objective of this study is to explore CDE and Ultrasound time during cataract extraction compared to Centurion.
This study will enroll 30 subjects (60 eyes) diagnosed with Nuclear Sclerosis cataract who require cataract surgery with intraocular lens implantation in both eyes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
First arm: Phacoemulsification using UNITY VCS/CS system with UNITY 4D phaco handpiece
Time frame: Intraoperative
CDE is a measure of the total ultrasound energy delivered into the eye during phacoemulsification cataract surgery
Time frame: Intraoperative
The time it takes to emulsify the lens material during cataract surgery
Time frame: Intraoperative
The total duration the surgeon spends removing lens material and cortical debris using the aspiration handpiece
Time frame: post op day 1
Onset and changes in corneal thickness after phacoemulsification performed by Unity vs Centurion Ozil, measured at the apex using Pentacam
Time frame: Post op day 1 and Post op day 7
Onset and changes in AC inflammation after phacoemulsification performed by Unity vs Centurion Ozil, Assessed during slit-lamp examination using SUN criteria
Time frame: Post op day 1
Onset and changes in Space between posterior capsule and vitreous body after phacoemulsification performed by Unity vs Centurion Ozil, measured by AS-OCT
Time frame: Post op day 7
Onset and changes in retinal thickness and incidents of CME after phacoemulsification performed with Unity vs Centurion Ozil, Measured by MAC OCT
Time frame: Post op day 7
Onset and changes in Average Ganglian Cell and Inner plexiform layer thickness after phacoemulsification performed with Unity vs Centurion Ozil, measured by OCT
Contact information is provided by the study sponsor or research team.
Nicole Fram M.D.
Other
Cumulative Dissipated Energy (CDE) and Total Phacoemulsification Energy (Joules) of Unity VCS/CS With 4D Phaco Compared to Centurion System With OZil
Acronym: CDE
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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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