Performance, Safety and Efficiency Comparison Between 10,000 and 5,000 Cuts Per Minute Vitrectomy Using a 25G Cutter - A Prospective Randomized Controlled Study
1 other identifier
interventional
52
1 country
1
Brief Summary
As technology advances, vitrectomy cutters are smaller and cut rates have become faster. In this prospective study, the vitrectomy efficiency and safety between 5,000 cuts per minute with 10,000 cuts per minute are compared
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 20, 2021
CompletedFirst Posted
Study publicly available on registry
April 26, 2021
CompletedApril 26, 2021
April 1, 2021
8 months
April 20, 2021
April 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Vitrectomy time
The time needed to remove all vitreous
1 day
Secondary Outcomes (2)
Safety and complications
up to 6 months
Number of instruments used
1 Day
Study Arms (2)
10k 25G cutter
EXPERIMENTALNew cutter, with a 10,000 cut per minute blade
5k 25G cutter
ACTIVE COMPARATORTraditional cutter, with a 5,000 cut per minute blade
Interventions
a proprietary Vitrector from Alcon for the use on the Constellation system
a proprietary Vitrector from Alcon for the use on the Constellation system
Eligibility Criteria
You may qualify if:
- Consecutive patients over the age of 18 requiring vitrectomy for vitreous haemorrhage (VH), epiretinal membrane (ERM), macular hole (MH), dislocated lens, rhegmatogenous retinal detachment and diabetic tractional retinal detachment were randomized into the study from January 2019 till August 2019
You may not qualify if:
- Patients with ocular comorbidities affecting surgical view including corneal opacities or scar, previous vitrectomy, history of trauma or requiring silicone oil were excluded from the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- Alcon Researchcollaborator
Study Sites (1)
University of Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Patients and Care provider are not able to differentiate the two different cutters since the port size are the exact same for both.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2021
First Posted
April 26, 2021
Study Start
May 1, 2018
Primary Completion
January 1, 2019
Study Completion
June 1, 2020
Last Updated
April 26, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share