A Cataract Surgery Clinical Trial
- Conditions
- Cataract
- Registration Number
- NCT07044674
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of the study is to compare the efficiency and safety of UNITY™ Vitreoretinal Cataract System (UNITY VCS) to CENTURION® Vision System with Active Sentry (CAS) in adult subjects with grade 2 or greater nuclear sclerotic cataracts who require phacoemulsification in both eyes. Subjects will attend a total of 8 scheduled visits for an individual duration of participation of approximately 1 month.
- Detailed Description
In this contralateral eye clinical study, one eye will undergo surgery with UNITY VCS and the other eye will undergo surgery with CAS. The second eye surgery will occur 0 to 14 days after the first eye surgery.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 125
- Clinically documented diagnosis of age-related nuclear sclerotic cataract of grade 2 or greater in both eyes;
- Both eyes with similar nuclear sclerotic cataract severity and type (within 1 cataract grade);
- Both eyes able to be implanted with same intraocular lens material;
- Both eyes able to receive the same ophthalmic viscosurgical device (OVD).
- Other protocol-specified inclusion criteria may apply.
Key
- Planned intraoperative glaucoma surgery or expected postoperative procedures during the study in either study eye;
- Laser-assisted cataract surgery in either study eye;
- Any ocular disease and/or condition that, in the investigator's clinical judgement, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
- Other protocol-specified exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cumulative Dissipated Energy (CDE) Day 0 surgery, each eye Cumulative Dissipated Energy (CDE) is the measure of energy released at the level of the corneal incision during cataract surgery. CDE will be recorded by the system.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (5)
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
Vance Thompson Vision
🇺🇸Sioux Falls, South Dakota, United States
Whitsett Vision Group
🇺🇸Spring, Texas, United States
Berkeley Eye Center
🇺🇸Sugar Land, Texas, United States
The Eye Institute of Utah
🇺🇸Salt Lake City, Utah, United States
Wolfe Eye Clinic🇺🇸West Des Moines, Iowa, United States