Comparison of Unity and Centurion phacoemulsification systems for bilateral cataract surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Immediate versus delayed bilateral cataract surgery in France

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.