Surgical Procedure Efficiency Evaluation stuDy (SPEED)
Research type
Research Study
Full title
Surgical Procedure Efficiency Evaluation stuDy (SPEED): Combination phaco-vitrectomy surgeries with UNITY VCS vs. Constellation in a real-world operating room setting
IRAS ID
358388
Contact name
Assad Jalil
Contact email
Sponsor organisation
Alcon Vision, LLC and its affiliates (“Alcon”)
Duration of Study in the UK
0 years, 7 months, 13 days
Research summary
The UNITY® Vitreoretinal Cataract System (VCS) console is expected to provide significant upgrades and innovation over existing technology which should enable improved efficiency in performing combined phacovitrectomy surgeries compared with
CONSTELLATION® Vision System.The objective of this study is to conduct a prospective, nonrandomized, observational, time-and-motion study assessing combined vitreoretinal and cataract
surgery (phacovitrectomy) efficiency for UNITY® VCS and CONSTELLATION® Vision System. Proportion of surgeon-reported overall Operating Room (OR) efficiency (including console turn-over and surgery) in each study cohort will be reported as the primary endpoint. Exploratory endpoints will examine differences between consoles in overall procedure time, procedure sub-step times and proportion of surgeons and scrub nurses reporting high console efficiency, high satisfaction and high ease of use. Additional data collection will be captured in an excel case report form (CRF) and will include patient demographics, and procedure characteristics. Phacovitrectomy procedures performed at one site in the United Kingdom as standard of care by 5 to 10 participating combined vitreoretinal and cataract surgeons to assess time for up to 180 cases in 2:1 ratio (up to 120 cases for the UNITY® VCS study arm and 60 cases for the CONSTELLATION® Vision System arm respectively).REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/LO/0716
Date of REC Opinion
16 Oct 2025
REC opinion
Further Information Favourable Opinion