Phacoemulsification Systems for Cataract

(CDE Trial)

Overseen By Orly Shiler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nicole Fram M.D.

Disqualifiers: Zonulopathy, Pupil devices, Ocular surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Intraoperative

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Nicole R Fram, M.D.

Principal Investigator

Advanced Vision Care

Are You a Good Fit for This Trial?

Inclusion Criteria

I am able to understand and agree to join the study.

I am 18 or older and having simple cataract surgery in both eyes.

Both eyes will be operated on by the same surgeon

Exclusion Criteria

I am under 18 years old.

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.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cataract surgery using either the Unity VCS/CS with 4D Phaco or Centurion system with OZil technology

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for changes in ganglion cell and inner plexiform layer thickness, macular thickness, and anterior chamber inflammation

1 week

2 visits (in-person)

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: Centurion vision system with OZil Handpiece Active Control 1 Intervention

Patients are generally randomized to undergo surgery with Centurion system with OZil technology phacoemulsification on one of there eyes

Group II: Unity VCS/CS with 4D Phaco Handpiece Active Control 1 Intervention

Patients are generally randomized to undergo surgery with Unity VCS/CS system with 4D phacoemulsification on one of there eyes

Who Is Running the Clinical Trial?

Nicole Fram M.D.

Lead Sponsor

Trials

3

Recruited

110+