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| ID | Type | Description | Link |
|---|---|---|---|
| 1405359 | Other Identifier | WCG IRB |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unity VCS/CS with 4D Phaco Handpiece | Active Comparator | Patients are generally randomized to undergo surgery with Unity VCS/CS system with 4D phacoemulsification on one of there eyes |
|
| Centurion vision system with OZil Handpiece | Active Comparator | Patients are generally randomized to undergo surgery with Centurion system with OZil technology phacoemulsification on one of there eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cataract extraction with phacoemulsification comparing two systems | Device | First arm: Phacoemulsification using UNITY VCS/CS system with UNITY 4D phaco handpiece |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Dissipated Energy | CDE is a measure of the total ultrasound energy delivered into the eye during phacoemulsification cataract surgery | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Total Ultrasound Time | The time it takes to emulsify the lens material during cataract surgery | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Total Aspiration Time | The total duration the surgeon spends removing lens material and cortical debris using the aspiration handpiece | Intraoperative |
| Central Corneal Thickness | Onset and changes in corneal thickness after phacoemulsification performed by Unity vs Centurion Ozil, measured at the apex using Pentacam |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Orly Shiler | Contact | 3102291220 | orlyjr@inorbit.com |
| Name | Affiliation | Role |
|---|---|---|
| Nicole R Fram, M.D. | Advanced Vision Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Vision Care | Recruiting | Los Angeles | California | 90067 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26316688 | Background | Erratum: Comparison of cumulative dissipated energy between the Infiniti and Centurion phacoemulsification systems [Corrigendum]. Clin Ophthalmol. 2015 Aug 19;9:1475. doi: 10.2147/OPTH.S93330. eCollection 2015. |
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In part due to : risk of Re-identification and Informed Consent Limitations.
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Contra-lateral eye design
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| Cataract extraction with phacoemulsification comparing two systems | Device | Second arm: Phacoemulsification using Centurion system with OZil technology |
|
| post op day 1 |
| Anterior chamber inflammation | Onset and changes in AC inflammation after phacoemulsification performed by Unity vs Centurion Ozil, Assessed during slit-lamp examination using SUN criteria | Post op day 1 and Post op day 7 |
| Presence of Berger space | Onset and changes in Space between posterior capsule and vitreous body after phacoemulsification performed by Unity vs Centurion Ozil, measured by AS-OCT | Post op day 1 |
| Macular thickness | Onset and changes in retinal thickness and incidents of CME after phacoemulsification performed with Unity vs Centurion Ozil, Measured by MAC OCT | Post op day 7 |
| Average Ganglian Cell and Inner plexiform layer thickness | Onset and changes in Average Ganglian Cell and Inner plexiform layer thickness after phacoemulsification performed with Unity vs Centurion Ozil, measured by OCT | Post op day 7 |
| ID | Term |
|---|---|
| C563333 | Cataract, Age-Related Nuclear |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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