Time Efficiency Comparison of Two IntraVitreal Injection Techniques (TIVI)
Primary Purpose
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion With Macular Edema
Status
Completed
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
Intravitreal injection guide (Malosa)
Dual Blade Eyelid Speculum
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring intravitreal injection, intravitreal injecton guide, macular edema, time efficiency, anti-VEGF
Eligibility Criteria
Inclusion Criteria:
* Eyes of adult patients requiring intravitreally injected medications for non-infectious indications
Exclusion Criteria:
- History of extraocular or intraocular infection within 3 months of the scheduled IVI date
- Scleral thinning
- History of previous glaucoma surgery
- History of pars plana vitrectomy
- Hypersensitivity to the IVI drug, proparacaine or povidone iodine
- Inability to understand the informed consent form
Sites / Locations
- Peregrine Eye and Laser Instittute
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Intravitreal injection guide
Dual blade eyelid speculum
Arm Description
Single use, combination ocular surface caliper to determine point of intravitreal injection and set-depth injection guide to limit injection needle entry into the eye
Dual blade eyelid speculum to open eyelids followed by Castroviejo surgical caliper to measure injection point 3.5 mm from limbus
Outcomes
Primary Outcome Measures
Duration of intravitreal injection procedure
Duration in seconds from application to removal of single-blade or dual blade speculum
Secondary Outcome Measures
Adverse event rate
Frequency of adverse events and serious adverse events after intravitreal injection
Patient preference for IVI technique
Patient survey as to which technique is more comfortable and preferred among patients with prior injection experience using the dual blade speculum
Full Information
NCT ID
NCT04455399
First Posted
June 28, 2020
Last Updated
April 25, 2021
Sponsor
Peregrine Eye and Laser Institute
1. Study Identification
Unique Protocol Identification Number
NCT04455399
Brief Title
Time Efficiency Comparison of Two IntraVitreal Injection Techniques
Acronym
TIVI
Official Title
Time Efficiency Comparison of Two Intravitreal Injection Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
January 9, 2021 (Actual)
Study Completion Date
January 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peregrine Eye and Laser Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective, single-center, randomized, clinical trial (RCT) comparing the time efficiency and safety of a single-use intravitreal injection (IVI) guide versus a traditional technique using a dual blade speculum among patients undergoing IVI for various indications.
Detailed Description
Prospective, single-center, randomized, clinical trial (RCT) comparing the efficiency and safety of a single-use IIG with a traditional technique using a dual blade speculum among patients undergoing IVI for various indications.
The investigators will include eyes of adult patients scheduled to undergo unilateral IVI for neovascular age-related macular degeneration (nAMD), polypoidal choroidal vasculopathy (PCV), diabetic macular edema (DME), retinal vein occlusion (RVO), choroidal neovascular membrane from pathologic myopia (PM) and uveitis. The investigators will exclude eyes with a history of extraocular or intraocular infection within 3 months of the scheduled IVI date, scleral thinning, history of previous glaucoma surgery, history of pars plana vitrectomy, hypersensitity to the IVI drug, propracaine or povidone iodine, and inability to understand the informed consent form.
The eyes will be randomly assigned in 1:1 fashion into two injection arms: intravitreal injection guide (IIG) and dual blade speculum (DBS). At the time of injection, a random number generator will be used to generate an odd or even number for each eye. Odd eyes will be assigned to IIG and even eyes will be assigned to DBS. For same day bilateral injection, once the first eye is randomized to one technique, the second eye will be automatically assigned to the other technique. The study will be conducted in compliance with the Declaration of Helsinki. All patients will provide informed consent prior to start of study procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion With Macular Edema, Uveitic Macular Edema, Choroidal Neovascularization
Keywords
intravitreal injection, intravitreal injecton guide, macular edema, time efficiency, anti-VEGF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intravitreal Injection Guide (Malosa, Beaver Visitec International, Waltham, MA)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravitreal injection guide
Arm Type
Other
Arm Description
Single use, combination ocular surface caliper to determine point of intravitreal injection and set-depth injection guide to limit injection needle entry into the eye
Arm Title
Dual blade eyelid speculum
Arm Type
Other
Arm Description
Dual blade eyelid speculum to open eyelids followed by Castroviejo surgical caliper to measure injection point 3.5 mm from limbus
Intervention Type
Device
Intervention Name(s)
Intravitreal injection guide (Malosa)
Other Intervention Name(s)
Malosa intravitreal injection guide
Intervention Description
A single use, multifunction device will be used to push away an eyelid to expose injection site, indicate injection point about 4 millimeters from surgical limbus, and directs needle perpendicular to the ocular surface while limiting intraocular needle incursion
Intervention Type
Device
Intervention Name(s)
Dual Blade Eyelid Speculum
Intervention Description
A conventional dual blade eyelid speculum will be use to push away eyelids. A Castroviejo surgical caliper will be used to mark the injection site.
Primary Outcome Measure Information:
Title
Duration of intravitreal injection procedure
Description
Duration in seconds from application to removal of single-blade or dual blade speculum
Time Frame
At time of injection procedure
Secondary Outcome Measure Information:
Title
Adverse event rate
Description
Frequency of adverse events and serious adverse events after intravitreal injection
Time Frame
Immediately and up to 1 month after the intravitreal injection procedure
Title
Patient preference for IVI technique
Description
Patient survey as to which technique is more comfortable and preferred among patients with prior injection experience using the dual blade speculum
Time Frame
Immediately post injection using single-blade speculum
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
* Eyes of adult patients requiring intravitreally injected medications for non-infectious indications
Exclusion Criteria:
History of extraocular or intraocular infection within 3 months of the scheduled IVI date
Scleral thinning
History of previous glaucoma surgery
History of pars plana vitrectomy
Hypersensitivity to the IVI drug, proparacaine or povidone iodine
Inability to understand the informed consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey S Uy, MD
Organizational Affiliation
Peregrine Eye and Laser Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peregrine Eye and Laser Instittute
City
Makati City
State/Province
MM
ZIP/Postal Code
1209
Country
Philippines
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34135566
Citation
Uy HS, Artiaga JCM. Comparison of Two Different Intravitreal Injection Techniques. Clin Ophthalmol. 2021 Jun 8;15:2383-2389. doi: 10.2147/OPTH.S309501. eCollection 2021.
Results Reference
derived
Learn more about this trial
Time Efficiency Comparison of Two IntraVitreal Injection Techniques
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