Ignite Creation Date:
2024-05-06 @ 1:38 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04076072
Status:
COMPLETED
Last Update Posted:
2022-10-21
First Post:
2019-08-29
Brief Title:
Beveled-Tip Versusvs Standard-Tip Vitrectomy Probe
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
High-speed Beveled Tip Versus Standard Tip Vitrectomy Probe a Prospective Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the efficiency of the new Utravit High-Speed 10000 cpm Beveled Probe to the current standard vitrector probe- Alcon non-beveled Ultravit 7500 cpm
Study Design
This is a randomized controlled trial comparing the efficiency of the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery
Hypothesis
The Advanced Ultravit high-speed beveled probe will show non-inferiority to the standard Alcon non-beveled Ultravit 7500 cpm with regards to time to completion of vitrectomy and surgical outcomes
Study Design
This is a randomized controlled trial comparing the efficiency of the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery
Hypothesis
The Advanced Ultravit high-speed beveled probe will show non-inferiority to the standard Alcon non-beveled Ultravit 7500 cpm with regards to time to completion of vitrectomy and surgical outcomes
Detailed Description:
High-speed beveled tip versus standard tip vitrectomy probe a prospective randomized clinical trial
Background
The Advanced Ultravit High-Speed Beveled Probe Alcon has a beveled-tip design that allows the cutting port to come closer to the retina compared to the previous vitrectr probe design This allows the surgeon to maneuver in tight tissue planes and increases the functionality of the vitrector probe This in combination with the increased cut rate of 10000 independent cuts per minute reduces traction on the retina and increases efficiency of vitreous removal
Purpose
The purpose of this study is to compare the efficiency of the new Utravit High-Speed 10000 cpm Beveled Probe to the current standard vitrector probe- Alcon non-beveled Ultravit 7500 cpm
Study Design
This is a prospective randomized controlled trial comparing the efficiency of the Advanced Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery
Primary objectives
-Intraoperative efficiency of vitrectomy surgery regarding time to completion of core vitrectomy and shave of vitreous base
Exploratory Objective
-Intraoperative complications eg iatrogenic retinal breaks intraocular bleeding retinal detachment
Postoperative complications
The study will not be sufficiently powered to assess safety Surgeons will want to make sure there is no significant increase in complications with a different probe However any post operative complications would merely be an association without any causality attributed
Primary Endpoint
A clinically significant difference in time to completion of core vitrectomy and shave of vitreous base between the two groups with 80 power at a 95 confidence interval
A p-value of less than 005 will be deemed as statistically significant
Sample Size Calculation Target 40 participants 20 in each cohort Assuming an average core vitrectomy time of 12 - 3 minutes a sample size of at least 32 is needed to adequately assess for a clinically significant difference between the two groups with 80 power at a 95 confidence interval A p-value of less than 005 will be deemed as statistically significant
Procedures and Assessments
All patients will undergo baseline testing in the study eye including
Best corrected Visual Acuity BCVA
intraocular pressure IOP
slit-lamp examination
360 degree indirect ophthalmoscopy
Enrollment Period
9 months
Study Duration
12 months
Methods
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 masked to the vitrector probe used Time to completion of vitrectomy and time to completion of vitreous base shave will be recorded by a masked timer
All examination will be repeated as regularly scheduled postoperative visits by a masked reader
Safety will be assessed at each visit by evaluation for any adverse events
Randomization
Randomization and data storage will occur in RedCap Patients will be randomized the day of surgery The randomization numbers will be generated using the following procedure to ensure that treatment assignment is unbiased and concealed from patients and investigator staff A patient randomization list will be produced by the IRT provider using a validated system that automates the random assignment of patient numbers to randomization numbers These randomization numbers are linked to the different treatment arms The randomization scheme for patients will be reviewed and approved by a member of the Randomization Group
Data collection measures
Unique Patient identifier
Vision
IOP
Oculus sinister Left Eye Ocular Dexter Right Eye
Surgical Indication
Time to completion of vitrectomy
Time to completion of vitreous base shave
Slit-lamp abnormalities
Dilated Fundus Exam DFE abnormalities
Post operation complications
Data collection April 2019 to Dec 2019
Data Analysis Jan 2020
Adverse Events
Reporting of Adverse Events Serious Adverse Events and Unanticipated Problems Involving Risk to Participants or Others will be reported to the Institutional Review Board IRB pursuant to their policy as outlined under the VANDERBILT HUMAN RESEARCH PROTECTIONS PROGRAM Policy IIIL
Safety
Risk Minimization
The study will be conducted in accordance with the International Conference on Harmonization ICH along with the Good Clinical Practices GCP guidelines and all applicable local and US federal regulatory requirements
Prior to entry into the study or initiation of any study related procedures the subject or legal representative must read sign and date the current institutional review board-approved version of the informed consent form Fully informed consent or verbal consent must be obtained from the subject or legal representative in accordance with local legal requirements and IRB requirements
Only potential subjects who meet the inclusionexclusion criteria will be enrolled in to this protocol The Principal Investigator will oversee all study procedures to ensure subject safety and protocol compliance
Risk v Benefits
The prospective subject will be carefully screened to ensure inclusionexclusion criteria are met
There may be no direct benefit to the subjects however the knowledge gained from this study may lead to improved methods of diagnosing staging and managing Vitrectomy surgery in the future
There will be no specific ethnic or age group targeted or excluded
Background
The Advanced Ultravit High-Speed Beveled Probe Alcon has a beveled-tip design that allows the cutting port to come closer to the retina compared to the previous vitrectr probe design This allows the surgeon to maneuver in tight tissue planes and increases the functionality of the vitrector probe This in combination with the increased cut rate of 10000 independent cuts per minute reduces traction on the retina and increases efficiency of vitreous removal
Purpose
The purpose of this study is to compare the efficiency of the new Utravit High-Speed 10000 cpm Beveled Probe to the current standard vitrector probe- Alcon non-beveled Ultravit 7500 cpm
Study Design
This is a prospective randomized controlled trial comparing the efficiency of the Advanced Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery
Primary objectives
-Intraoperative efficiency of vitrectomy surgery regarding time to completion of core vitrectomy and shave of vitreous base
Exploratory Objective
-Intraoperative complications eg iatrogenic retinal breaks intraocular bleeding retinal detachment
Postoperative complications
The study will not be sufficiently powered to assess safety Surgeons will want to make sure there is no significant increase in complications with a different probe However any post operative complications would merely be an association without any causality attributed
Primary Endpoint
A clinically significant difference in time to completion of core vitrectomy and shave of vitreous base between the two groups with 80 power at a 95 confidence interval
A p-value of less than 005 will be deemed as statistically significant
Sample Size Calculation Target 40 participants 20 in each cohort Assuming an average core vitrectomy time of 12 - 3 minutes a sample size of at least 32 is needed to adequately assess for a clinically significant difference between the two groups with 80 power at a 95 confidence interval A p-value of less than 005 will be deemed as statistically significant
Procedures and Assessments
All patients will undergo baseline testing in the study eye including
Best corrected Visual Acuity BCVA
intraocular pressure IOP
slit-lamp examination
360 degree indirect ophthalmoscopy
Enrollment Period
9 months
Study Duration
12 months
Methods
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 masked to the vitrector probe used Time to completion of vitrectomy and time to completion of vitreous base shave will be recorded by a masked timer
All examination will be repeated as regularly scheduled postoperative visits by a masked reader
Safety will be assessed at each visit by evaluation for any adverse events
Randomization
Randomization and data storage will occur in RedCap Patients will be randomized the day of surgery The randomization numbers will be generated using the following procedure to ensure that treatment assignment is unbiased and concealed from patients and investigator staff A patient randomization list will be produced by the IRT provider using a validated system that automates the random assignment of patient numbers to randomization numbers These randomization numbers are linked to the different treatment arms The randomization scheme for patients will be reviewed and approved by a member of the Randomization Group
Data collection measures
Unique Patient identifier
Vision
IOP
Oculus sinister Left Eye Ocular Dexter Right Eye
Surgical Indication
Time to completion of vitrectomy
Time to completion of vitreous base shave
Slit-lamp abnormalities
Dilated Fundus Exam DFE abnormalities
Post operation complications
Data collection April 2019 to Dec 2019
Data Analysis Jan 2020
Adverse Events
Reporting of Adverse Events Serious Adverse Events and Unanticipated Problems Involving Risk to Participants or Others will be reported to the Institutional Review Board IRB pursuant to their policy as outlined under the VANDERBILT HUMAN RESEARCH PROTECTIONS PROGRAM Policy IIIL
Safety
Risk Minimization
The study will be conducted in accordance with the International Conference on Harmonization ICH along with the Good Clinical Practices GCP guidelines and all applicable local and US federal regulatory requirements
Prior to entry into the study or initiation of any study related procedures the subject or legal representative must read sign and date the current institutional review board-approved version of the informed consent form Fully informed consent or verbal consent must be obtained from the subject or legal representative in accordance with local legal requirements and IRB requirements
Only potential subjects who meet the inclusionexclusion criteria will be enrolled in to this protocol The Principal Investigator will oversee all study procedures to ensure subject safety and protocol compliance
Risk v Benefits
The prospective subject will be carefully screened to ensure inclusionexclusion criteria are met
There may be no direct benefit to the subjects however the knowledge gained from this study may lead to improved methods of diagnosing staging and managing Vitrectomy surgery in the future
There will be no specific ethnic or age group targeted or excluded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None