Comparison of Unity and Centurion phacoemulsification systems for bilateral cataract surgery
Cumulative Dissipated Energy (CDE) and Total Phacoemulsification Energy (Joules) of Unity VCS/CS With 4D Phaco Compared to Centurion System With OZil
This test compares the Unity and Centurion phacoemulsification systems to see which uses less ultrasound time and cumulative dispersed energy in adults having sequential bilateral cataract surgery for nuclear sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Advanced Vision Care Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07468877 on ClinicalTrials.gov |
What this trial studies
Unity and Centurion are two phacoemulsification platforms used to remove cataractous lenses; this study compares their performance during standard bilateral cataract extraction with intraocular lens implantation. The trial will enroll 30 subjects (60 eyes) with LOCS III grade 3 or higher nuclear sclerosis who are scheduled for uncomplicated sequential bilateral phacoemulsification, with both eyes operated on by the same surgeon. During each procedure the study will record cumulative dispersed energy (CDE) and ultrasound time to allow direct within-patient comparison between systems. Subjects with complex zonular pathology, need for pupil expansion devices, or other factors that could affect the surgical procedure are excluded.
Who should consider this trial
Good fit: Adults (18+) with bilateral nuclear sclerosis cataracts graded LOCS III 3 or higher who are scheduled for uncomplicated sequential bilateral phacoemulsification with IOL implantation and can consent are ideal candidates.
Not a fit: Patients with complex cataracts (zonulopathy, need for capsular support or pupil expansion devices), those undergoing femtosecond-assisted procedures, unilateral cataracts, or patients under 18 are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, one system could be shown to use less ultrasound energy and time, which may reduce corneal endothelial stress and speed visual recovery.
How similar studies have performed: Previous device-to-device comparisons of phacoemulsification platforms have reported measurable differences in CDE and ultrasound time, so the approach is established though results depend on surgeon technique and case mix.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy patients 18 years or older undergoing uncomplicated sequential bilateral cataract surgery with phacoemulsification and IOL implantation * Expected to undergo sequential cataract surgery in both eyes * Must have bilateral nuclear sclerosis cataracts classified using LOCS III as grade 3 or above (see appendix III) * Both eyes will be operated on by the same surgeon * Have the ability to consent for study and procedure planned Exclusion Criteria: * Patients under 18 years of age. * Complex cataract cases involving zonulopathy (e.g., pseudoexfoliation syndrome, traumatic zonular weakness) that may require use of zonular support devices during surgery (e.g. capsular hooks) and/or implantation of capsular tension rings or other zonular support devices, and in the investigator's judgment, may interfere with the surgical procedure or study outcome measures. * Require mechanical pupil expanding devices (e.g., iris hooks, Malyugin rings, etc.) * Undergoing femtosecond laser-assisted lens fragmentation. * Surgical complications, in the opinion of the investigator, occurring either intraoperatively or postoperatively (including capsule tears, iris trauma, or decentered intraocular lens) and not attributable to the study device or study design. * Prior ocular surgery (including intraocular, oculoplastic, corneal or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment, if it interferes with the outcome measures of this study. * Presence of endothelial cell dystrophies and/or corneal comorbidities. * History of intraocular inflammation (e.g., uveitis, iritis). * History of retinal edema or presence of a clinically significant epiretinal membrane that, in the investigator's clinical judgment, may interfere with the outcome measures of this study. * History of retinal surgery (e.g.retinal detachment repair, membrane peel) involving vitrectomy. * Dense brunescent cataract that in the investigator's clinical judgment, may interfere with the outcome measures of this study.
Where this trial is running
Los Angeles, California
- Advanced Vision Care — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Nicole R Fram, M.D. — Advanced Vision Care
- Study coordinator: Orly Shiler
- Email: orlyjr@inorbit.com
- Phone: 3102291220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.