Trial Outcomes & Findings for Beveled-Tip Versus(vs) Standard-Tip Vitrectomy Probe (NCT NCT04076072)
NCT ID: NCT04076072
Last Updated: 2022-10-21
Results Overview
Intraoperative efficiency of vitrectomy surgery regarding time to completion of core vitrectomy and shave of vitreous base
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Time to completion of core vitrectomy and shave of vitreous base (12 ± 3 minutes )
Results posted on
2022-10-21
Participant Flow
Of 40 enrolled participants, 40 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Alcon Advanced Ultravit High-Speed Vitrectomy Probe
On the day of surgery, patients will be randomized to the Ultravit High-Speed Beveled Probe or the current non-beveled Alcon Probe. All patients will undergo routine vitrectomy surgery as scheduled; patients will be unaware of the vitrector probe used. Time to completion of vitrectomy and time to completion of vitreous base shave will be recorded by study staff unaware of the vitrector probe used. All examination will be repeated as regularly scheduled postoperative visits by a reader unaware of which probe was used. Safety will be assessed at each visit by evaluation for any adverse events.
Utravit High-Speed 10000 cpm Beveled Probe: This is a randomized controlled trial comparing the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery.
|
Alcon Non-Beveled Tip Vitrectomy Probe
On the day of surgery, patients will be randomized to the Ultravit High-Speed Beveled Probe or the current non-beveled Alcon Probe. All patients will undergo routine vitrectomy surgery as scheduled; patients will be unaware of the vitrector probe used. Time to completion of vitrectomy and time to completion of vitreous base shave will be recorded by study staff unaware of the vitrector probe used. All examination will be repeated as regularly scheduled postoperative visits by a reader unaware of which probe was used. Safety will be assessed at each visit by evaluation for any adverse events.
standard vitrector probe- Alcon (non-beveled) Ultravit 7500 cpm: This is a randomized controlled trial comparing the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Beveled-Tip Versus(vs) Standard-Tip Vitrectomy Probe
Baseline characteristics by cohort
| Measure |
Alcon Advanced Ultravit High-Speed Vitrectomy Probe
n=20 Participants
On the day of surgery, patients will be randomized to the Ultravit High-Speed Beveled Probe or the current non-beveled Alcon Probe. All patients will undergo routine vitrectomy surgery as scheduled; patients will be unaware of the vitrector probe used. Time to completion of vitrectomy and time to completion of vitreous base shave will be recorded by study staff unaware of the vitrector probe used. All examination will be repeated as regularly scheduled postoperative visits by a reader unaware of which probe was used. Safety will be assessed at each visit by evaluation for any adverse events.
Utravit High-Speed 10000 cpm Beveled Probe: This is a randomized controlled trial comparing the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery.
|
Alcon Non-Beveled Tip Vitrectomy Probe
n=20 Participants
On the day of surgery, patients will be randomized to the Ultravit High-Speed Beveled Probe or the current non-beveled Alcon Probe. All patients will undergo routine vitrectomy surgery as scheduled; patients will be unaware of the vitrector probe used. Time to completion of vitrectomy and time to completion of vitreous base shave will be recorded by study staff unaware of the vitrector probe used. All examination will be repeated as regularly scheduled postoperative visits by a reader unaware of which probe was used. Safety will be assessed at each visit by evaluation for any adverse events.
standard vitrector probe- Alcon (non-beveled) Ultravit 7500 cpm: This is a randomized controlled trial comparing the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
10 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=113 Participants
|
17 Participants
n=163 Participants
|
30 Participants
n=160 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=113 Participants
|
9 Participants
n=163 Participants
|
21 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=113 Participants
|
11 Participants
n=163 Participants
|
19 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=113 Participants
|
20 Participants
n=163 Participants
|
40 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=113 Participants
|
20 participants
n=163 Participants
|
40 participants
n=160 Participants
|
|
Pathology Requiring Vitreoretinal Surgery
Epiretinal Membrane
|
2 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
|
Pathology Requiring Vitreoretinal Surgery
Vitreous Opacities or Hemorrhage
|
10 Participants
n=113 Participants
|
13 Participants
n=163 Participants
|
23 Participants
n=160 Participants
|
|
Pathology Requiring Vitreoretinal Surgery
Vitreomacular Traction or Macular Hole
|
8 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
12 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Time to completion of core vitrectomy and shave of vitreous base (12 ± 3 minutes )Intraoperative efficiency of vitrectomy surgery regarding time to completion of core vitrectomy and shave of vitreous base
Outcome measures
| Measure |
Alcon Advanced Ultravit High-Speed Vitrectomy Probe
n=20 Participants
On the day of surgery, patients will be randomized to the Ultravit High-Speed Beveled Probe or the current non-beveled Alcon Probe. All patients will undergo routine vitrectomy surgery as scheduled; patients will be unaware of the vitrector probe used. Time to completion of vitrectomy and time to completion of vitreous base shave will be recorded by study staff unaware of the vitrector probe used. All examination will be repeated as regularly scheduled postoperative visits by a reader unaware of which probe was used. Safety will be assessed at each visit by evaluation for any adverse events.
Utravit High-Speed 10000 cpm Beveled Probe: This is a randomized controlled trial comparing the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery.
|
Alcon Non-Beveled Tip Vitrectomy Probe
n=20 Participants
On the day of surgery, patients will be randomized to the Ultravit High-Speed Beveled Probe or the current non-beveled Alcon Probe. All patients will undergo routine vitrectomy surgery as scheduled; patients will be unaware of the vitrector probe used. Time to completion of vitrectomy and time to completion of vitreous base shave will be recorded by study staff unaware of the vitrector probe used. All examination will be repeated as regularly scheduled postoperative visits by a reader unaware of which probe was used. Safety will be assessed at each visit by evaluation for any adverse events.
standard vitrector probe- Alcon (non-beveled) Ultravit 7500 cpm: This is a randomized controlled trial comparing the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery.
|
|---|---|---|
|
Time to Completion of Core Vitrectomy and Shave of Vitreous Base
|
9.7 minutes
Standard Deviation 2
|
10.4 minutes
Standard Deviation 1.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsParticipants in each study arm experiencing intraoperative complications (e.g. iatrogenic retinal breaks, intraocular bleeding, retinal detachment)
Outcome measures
| Measure |
Alcon Advanced Ultravit High-Speed Vitrectomy Probe
n=20 Participants
On the day of surgery, patients will be randomized to the Ultravit High-Speed Beveled Probe or the current non-beveled Alcon Probe. All patients will undergo routine vitrectomy surgery as scheduled; patients will be unaware of the vitrector probe used. Time to completion of vitrectomy and time to completion of vitreous base shave will be recorded by study staff unaware of the vitrector probe used. All examination will be repeated as regularly scheduled postoperative visits by a reader unaware of which probe was used. Safety will be assessed at each visit by evaluation for any adverse events.
Utravit High-Speed 10000 cpm Beveled Probe: This is a randomized controlled trial comparing the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery.
|
Alcon Non-Beveled Tip Vitrectomy Probe
n=20 Participants
On the day of surgery, patients will be randomized to the Ultravit High-Speed Beveled Probe or the current non-beveled Alcon Probe. All patients will undergo routine vitrectomy surgery as scheduled; patients will be unaware of the vitrector probe used. Time to completion of vitrectomy and time to completion of vitreous base shave will be recorded by study staff unaware of the vitrector probe used. All examination will be repeated as regularly scheduled postoperative visits by a reader unaware of which probe was used. Safety will be assessed at each visit by evaluation for any adverse events.
standard vitrector probe- Alcon (non-beveled) Ultravit 7500 cpm: This is a randomized controlled trial comparing the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery.
|
|---|---|---|
|
Number of Participants With Intraoperative Complications
|
0 Participants
|
0 Participants
|
Adverse Events
Alcon Advanced Ultravit High-Speed Vitrectomy Probe
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcon Non-Beveled Tip Vitrectomy Probe
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place