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
Sponsors and collaborators
Nicole Fram M.D.
Lead sponsor
Advanced Vision Care
Sponsor institution