High-speed Beveled Tip Versus Standard Tip Vitrectomy Probe: a Prospective Randomized Clinical Trial
Phase: NA
Conditions: Vitrectomy
Sponsor: Vanderbilt University Medical Center

Identifiers: NCT04076072   Unique Protocol ID: 190728 
Brief Title: High-speed Beveled Tip Versus Standard Tip Vitrectomy 
Probe: a Prospective Randomized Clinical Trial  
 
 
Document Date: Document Date: March 1, 2019 
 
Study Protocol 
 
 

Contact Information 
*First Name 
Shriji   
*Last Name 
Patel   
Address 
2311 Pierce Avenue   
City 
Nashville   
State 
Tennessee 
  
Zip 
37232  
*Telephone 
2019256754   
*E-mail Address 
Shriji.patel@vanderbilt.edu   
*Country 
United States 
  
Organization/Institution Information 
*Organization/Institution Name 
Vanderbilt University Medical Center   
 
 
Proposal Summary 
*What type of study is your request? 
Clinical Study 
  
*Therapeutic Area 
Surgical 
  
Surgical Area 
Retina 
  
*Proposal Title 
Comparison of beveled-tip vs. standard-tip 
vitrectomy probe  
*Preferred submission option 
 
 
 
 
 
 
 
 
 
 
 
 
 
Proposal Summary 

 
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 vitrector 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 10,000 independent cuts per minute reduces traction on the 
retina and increases efficiency of vitreous removal.   
 
 
 
 
Purpose 
-Compare the efficiency and safety of the new Utravit High-Speed Beveled Probe compared to the current 
standard vitrector probe. 
 
Primary objectives: 
-Time to completion of core vitrectomy 
-Time to completion of shave of vitreous base 
 
Secondary objectives: 
-Intraoperative complications (e.g. iatrogenic retinal breaks, intraocular bleeding, retinal detachment) 
-Postoperative complications 
 
Enrollment Period: 
9 months 
 
Study Duration: 
12 months 
 
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 0.05 will be deemed as statistically significant.   
 
Study Design: 
This is a prospective, randomized controlled trial comparing the efficiency and safety of the Ultravit 
High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing 
routine vitrectomy surgery.   
 

Inclusion criteria: 
The study population will be male and female patients 18 years old or older with the presence of 
pathology requiring vitreoretinal surgery (vitreous opacities, vitreous hemorrhage, vitreomacular traction, 
macular hole, epiretinal membrane) without previous history of vitreoretinal surgery.  
 
Written informed consent must be obtained before any enrollment in the study 
 
Exclusion criteria: 
-Previous incisional intraocular surgery other than uncomplicated cataract surgery with intraocular lens 
placement 
-Inability to consent for procedure 
 
Procedures and Assessments: 
All patients will undergo baseline testing in the study eye including: 
-BCVA 
-intraocular pressure 
-slit-lamp examination 
-360 degree indirect ophthalmoscopy 
 
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.