Cataract
Conditions
Keywords
Phacoemulsification, Anterior segment
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.
Interventions
UNITY VCS is a commercially approved surgical system that facilitates the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during eye surgery. It consists of a console, remote control, foot controller, video overlay, and compatible anterior segment devices. In this study, it will be used for the removal of cataracts.
DEVICECENTURION Vision System with Active Sentry
CAS is a commercially approved surgical system for use during anterior segment ophthalmic surgery. It consists of a console, foot controller, remote control, video overlay, and compatible anterior segment devices. The Active Sentry handpiece will be used.
PROCEDUREAnterior segment ophthalmic surgery
Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification)
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed