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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNicole Fram M.D.

About 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

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Cataract extraction with phacoemulsification comparing two systems
  • Cataract extraction with phacoemulsification comparing two systems

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nicole Fram M.D.

Lead sponsor

Advanced Vision Care

Sponsor institution