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

Recruiting now · Not applicable

Conditions studied: Nuclear Sclerosis of the Lens, Phacoemulsification Cataract Surgery, Cataract Bilateral

In brief

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

Key facts

Study ID

NCT07468877

Run by

Nicole Fram M.D.

People needed

30

Starts

2026-02-13

Expected to finish

2027-02-13

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Advanced Vision Care — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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