Cataract, Macular Holes, Macular Pucker, Retinal Detachment, Vitreous Hemorrhage
Conditions
Keywords
anterior segment ophthalmic surgery, posterior segment ophthalmic surgery
Brief summary
The purpose of this real-world evidence study is to compare surgical procedure times for UNITY® VCS and CONSTELLATION® Vision System.
Detailed description
Eligible subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy). This single visit, time-and-motion study will be conducted in the United Kingdom. This study will be conducted by Alcon Vision LLC.
Interventions
DEVICEUNITY VCS
UNITY® VCS is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy).
DEVICECONSTELLATION
CONSTELLATION is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy).
Sponsors
Alcon Research
Manchester Royal Eye Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Able to understand and sign an informed consent form (ICF) that has been approved by an ethics committee. * Planned combined phacovitrectomy procedure at one of the selected surgical sites. * Planned combined phacovitrectomy procedure with 25-gauge (G) vitrectomy tools. Key
Exclusion criteria
* Unplanned/emergency phacovitrectomy. * Pregnant. * Past history of phacovitrectomy. cataract, vitrectomy in the planned operative eye. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of surgeons replying "efficient" or "very efficient" to the question, "How would you rate overall OR (operating room) efficiency of the console for the combined phaco-vitrectomy surgery (including set-up/tear-down)? | Up to Day 1 post completion of the surgery | Responses will be collected on a 5-point scale where 1=Very Inefficient, 2=Inefficient, 3=Neutral, 4=Efficient, and 5=Very Efficient. |
Countries
United Kingdom
Contacts
CONTACTAlcon Call Center
STUDY_DIRECTORManager, Health Economics/Outcomes Research
Alcon Research, LLC
Outcome results
None listed